FDA Adverse Event Malfunction Summary report: N

HEARTSINE SAMARITAN 300P AND PAD PAK

MDR report key: 2932578 · Received January 23, 2013

Report

Report Number: 3004123209-2013-00112
Event Type: Malfunction
Date Received: January 23, 2013
Date of Event: July 17, 2011
Report Date: January 9, 2013
Manufacturer: HEARTSINE TECHNOLOGIES, LTD
Product Code: MKJ
PMA / PMN Number: K052465
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE PAD DEVICE WAS INSTALLED ON (B)(6) 2008 AND OPERATED SUCCESSFULLY UNTIL (B)(6) 2011. ON THIS DATE THE DEVICE FAILS ITS WEEKLY SELF TEST DUE TO A LOW BATTERY. THE USER WAS ALERTED BY A FLASHING RED LED AND AN AUDIBLE BEEP. 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 BATTERY HAD BEEN IN USE FOR 2 YEARS AND 10 MONTHS. THE PAD-PAK HAD BEEN REMOVED AFTER THE SELF TEST FAILURE AND WAS THEN RE-INSERTED, WHICH IS AGAINST RECOMMENDED PRACTICE BUT IN THIS INSTANCE THE DEVICE STATUS LED TURNED GREEN INDICATING IT WAS CAPABLE OF GIVING THERAPY IF REQUIRED. THE PAD PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELLED FOR SINGLE USE BUT THE SAMARITAN PAD 300 AND 300P DEVICES ARE FOR MULTI-USE.

Description of Event or Problem · 1

THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE THE STATUS INDICATOR WAS FLASHING RED ONE DAY AND REMAINED ON AND WAS GREEN THE NEXT DAY. A DEVICE IN THIS FAULT MODE, IF LEFT UNDETECTED COULD RESULT IN THE FAILURE OF THE DEVICE TO PERFORM AS INTENDED IF REQUIRED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
33276	HEARTSINE SAMARITAN 300P AND PAD PAK	AUTOMATED EXTERNAL DEFIBRILLATOR	MKJ	HEARTSINE TECHNOLOGIES, LTD	PAD

Patients

Seq	Age	Sex	Outcome	Treatment
1