Revatio (re-vah-tee-o) is a fairly new drug on the market used to treat pulmonary hypertension.  Pulmonary hypertension causes increased blood pressure in the blood vessels of the lungs.  Because of this, patients are not able to tolerate physical activity and exercise as they used to.  You may find patients with COPD that also have pulmonary hypertension.  It is very important for all EMS providers to be aware of Revatio because it is made of the same drug as Viagra.  The generic name for Viagra and Revatio is sildenafil (sill-dena-fill).  Patients on Revatio are contraindicated from receiving Nitroglycerin the same as those on Viagra, Levitra or Cialis.  Administration of nitroglycerin to a patient on Revatio could cause a sudden and severe drop in blood pressure.  This is an important thing to remember because oftentimes the patient is on a generic form of a drug rather than the brand name.  Look for patients with a history of chronic breathing problems—especially when brought on by exertion, to be on Revatio.  If you encounter a patient taking Revatio that has indications for nitroglycerin (chest pain), document that the patient is on Revatio and therefore, is unable to receive nitroglycerin.  As a reminder, the State and Regional protocol for withholding nitroglycerin has been increased to 72 hours in the presence of Viagra, Levitra, and Cialis (erectile dysfunction drugs).  You can find additional information at: http://www.drugs.com/pro/revatio.html

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Recall Class: Class I

Date Recall Initiated: May 21, 2010

Product(s): DBP-2800 Battery Pack for the Defibtech ReviveR AED™ and Lifeline AED® semi-automatic external defibrillators

Affects only DBP-2800 battery packs distributed prior to June 4, 2007 and used with the ReviveR AED™ and Lifeline AED® devices.

Affected battery pack serial numbers range:

• Between 202001005 and 202005916, or,
• Between 206001001 and 206009871

In a letter to customers dated May 20, 2010, Defibtech states that the company is mailing to all affected customers a battery pack update data card that will allow customers to update device software to correct the problem while allowing the devices to remain in their locations.

Defibtech notification and instructions on determining whether a battery pack is affected.

Reason for Recall: If the AED is used with an affected battery pack, the AED may falsely detect an error condition, cancel charge and not provide therapy.

For further info-  http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm215407.htm

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Recall Class: Class I

Date Recall Initiated: March 4, 2010

Product(s): LIFEPAK 15 Monitor/Defibrillator

See under Useful Links to search for affected devices by serial number.
The serial number is located on the underside of the device.

These devices were manufactured between March 26, 2009 and December 15, 2009 and distributed between March 27, 2009 and December 15, 2009.

Use: The LIFEPAK 15 monitor/defibrillator is designed for use by trained medical personnel in out-of-doors and indoor emergency care settings to monitor patient heart rhythms and to treat patients experiencing cardiac arrest.

Recalling Firm:
Physio-Control, Inc.
11811 Willows Road NE
Redmond, Washington 98052-2003

Reason for Recall: There is a potential for the device to unexpectedly:

• Power Off then On by itself.
• Power Off then NOT turn On.
• Power Off by itself requiring the operator to turn it back On.
• Stay powered On and not allow itself to be turned Off.

Public Contact: Physio-Control Technical Support at

via List of Medical Device Recalls Physio-Control Inc., LIFEPAK 15 Monitor/Defibrillator.

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http://www.fda.gov/Safety/Recalls/ucm220227.htm

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An investigation has shown that these batteries were more than 2 years past the manufacturers suggested replacement date. There also seems to have been a failure to identify the dead batteries due to a regular checkout of the defibrillator. There has been a settlement of 3.2 Million dollars in this case (which would have more than paid for those batteries).

Beyond the dollars involved we must remember what got most of us (from the field provider to the administrator)  into this business – the desire to help someone.

Lets keep our eye on the ball and ensure we do everything possible to provide that high level of care we all talk about.

By the way, we may save our self a load of money on the side!

Failure to maintain the batteries in an AED has resulted in a $3.2 million dollar (USD) settlement being awarded to the family of a 49 year-old man who died from a heart attack in which the defibrillator batteries did not work. Frederick Partyka, a stationary engineer who worked for the city of Chicago, was using a snow blower in front of his home in the 2700 block of North New England when he collapsed on Jan. 22, 2005. Partyka’s son, a paramedic with the Hillside Fire Department, witnessed the incident, called 911 and administered CPR to his father while waiting for help.
When the fire engine arrived at 3:16 p.m., the paramedic found Partyka in ventricular tachycardia, a life-threatening condition. But when the paramedic attempted to shock Partyka’s heart back into rhythm, the defibrillator didn’t work, a lawyer for the Partyka family said. The batteries were old and did not hold a charge. When the old batteries were replaced with spare batteries, the defibrillator powered off again, the lawyer said. At 3:22 p.m., an ambulance arrived with a working defibrillator. But it was too late. Partyka was already dead.
“The industry standard required — and the manufacturer recommended — that this particular defibrillator battery had to be replaced every two years,” said Susan Schwartz, an attorney representing the Partyka family. “But, on Jan. 22, 2005, no battery had been purchased by the city since October 2000. They didn’t properly maintain the batteries for these defibrillators.” During Monday’s Finance Committee meeting, First Deputy Corporation Counsel Karen
Seimetz told aldermen that the defibrillators used on that day were replaced in March 2005. The new version uses batteries “automatically changed out with the manufacturer every two years,” she said. “In the thousands and thousands and thousands of times these defibrillators have been used, this is the first known instance where this has ever occurred,” she said.
Under questioning from aldermen, Seimetz acknowledged that no one knows whether a working defibrillator would have saved Partyka. But, she said, “The problem is under the law, if there’s any percentage chance that a person could have survived but for the alleged negligence, that’s enough to recover [damages]. Even though he had an underlying heart disease, this might have made the difference. There was no damage to the heart on autopsy.”

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