FDA Adverse Event Malfunction Summary report: N

HEARTSINE SAMARITAN 300P AND PAD PAK

MDR report key: 2932575 · Received January 23, 2013

Report

Report Number: 3004123209-2013-00115
Event Type: Malfunction
Date Received: January 23, 2013
Date of Event: November 28, 2010
Report Date: January 10, 2013
Manufacturer: HEARTSINE TECHNOLOGIES, LTD
Product Code: MKJ
PMA / PMN Number: K052465
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE PAD DEVICE WAS INSTALLED ON (B)(6) 2008 AND OPERATED SUCCESSFULLY UNTIL (B)(6) 2010. THE SELF FAIL WAS DUE TO A LOW BATTERY. A NEW PAD-PAK WAS THEN INSTALLED ON OR BEFORE (B)(6) AND PERFORMED AS EXPECTED UNTIL (B)(6) 2011. THERE IS NO EVIDENCE OF THE DEVICE SWITCHING ITSELF ON. THE DEVICE FAILED A SELF TEST ON (B)(6) 2010 BECAUSE OF A LOW BATTERY, TWO YEARS AND FOUR MONTHS AFTER INSTALLATION. ALTHOUGH NO FAULT WAS FOUND WITH THE PAD OR PAD-PAK. THE PAD-PAK WAS DEPLETED TO THE POINT IT TRIGGERED THE BATTERY MANAGEMENT SYSTEM IN THE DEVICE. THE BATTERIES CAN BE DEPLETED BY A VARIETY OF CONDITIONS INCLUDING THE STORAGE LOCATION OF THE DEVICE, AGE OF BATTERY PACK AND LEVEL OF MANUAL INTERVENTION. THE PAD PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELED FOR SINGLE USE, BUT THE SAMARITAN PAD 300 AND 300P DEVICES ARE FOR MULTI-USE.

Description of Event or Problem · 1

THERE WAS NO PT INVOLVED IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE IT WAS SWITCHING ITSELF ON AUTOMATICALLY. A DEVICE SWITCHING ITSELF ON AUTOMATICALLY, IF LEFT UNDETECTED, COULD RESULT IN THE BATTERY BECOMING DEPLETED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
33275	HEARTSINE SAMARITAN 300P AND PAD PAK	AUTOMATED EXTERNAL DEFIBRILLATOR	MKJ	HEARTSINE TECHNOLOGIES, LTD	PAD

Patients

Seq	Age	Sex	Outcome	Treatment
1