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Class I Medical Device Recall: HeartSine Samaritan Public Access Defibrillator 300/300P

Mon, 11/19/2012 - 12:00am
U.S. Food & Drug Administration

Recall Class: Class I

Date Recall Initiated: 09/13/2012

Product(s): HeartSine Samaritan 300/300P Public Access Defibrillator (PAD)

Model/catalog/lot numbers: Samaritan 300/300P PAD devices with the following serial numbers are affected by this recall:

Serial numbers

  • 0400000501 to 0700032917
  • 08A00035000 to 10A0070753
  • 10C00200000 to 10C00210106

Range of manufacturing and distribution dates: Manufactured and distributed from 08/01/2004 to 01/31/2011.

Use: The device is intended for use on patients experiencing sudden cardiac arrest.

Recalling Firm:
HeartSine Technologies, Limited
203 Airport Road West
Belfast, Northern Ireland BT3 9ED

Distributor:
HeartSine Technologies, Limited
121 Friends Lane, Suite 400
Newtown, PA 18940

Reason for Recall:

The firm issued a letter to customers on Sept. 11, 2012 describing the problem and provided instructions for correction. Certain Samaritan® 300/300P PAD devices have been found to intermittently turn on and off, which may eventually deplete the battery.  In addition and separately, certain Samaritan 300/300P PAD devices containing early versions of the battery management software may misinterpret a temporary drop in battery voltage as signaling a low battery resulting in the device turning itself off.  A device experiencing either condition could be unable to deliver therapy during a cardiac event.

Public Contact: Consumers with questions may contact the company at 1-877-877-0147 between the hours of 8:00am and 5:00 pm ET and email at heartsine6265@stericycle.com.

FDA District: Philadelphia

FDA Comments:

HeartSine has requested that customers follow the instructions detailed in their letter dated Sept. 11, 2012 to ensure that affected devices are able to provide therapy if a sudden cardiac arrest event occurs.

No deaths or injuries have been reported to date associated with the on/off issue.  To date, HeartSine has received five reports of death for which the company has not been able to rule out the possibility that the events may have been related to the battery management software issue.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Additional Links:

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