FDA Adverse Event Malfunction Summary report: N

HEARTSINE SAMARITAN 300P AND PAD PAK

MDR report key: 2932571 · Received January 23, 2013

Report

Report Number: 3004123209-2013-00119
Event Type: Malfunction
Date Received: January 23, 2013
Date of Event: December 28, 2008
Report Date: January 10, 2013
Manufacturer: HEARTSINE TECHNOLOGIES, LTD
Product Code: MKJ
PMA / PMN Number: K052465
Product Problem: Yes
Report Source: Manufacturer report
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. ON OR AFTER THIS DATE THERE ARE MULTIPLE EVENTS ON THE SAME DAY WHICH WOULD INDICATE THE DEVICE WAS SWITCHING ITSELF ON AUTOMATICALLY. THERE ARE NO AUTOMATIC SELF TESTS RECORDED BETWEEN (B)(6) 2008 AND (B)(6) 2011 WHEN THE COMPLAINT WAS REPORTED. THE DEVICE WAS DISASSEMBLED FOR INVESTIGATION AND SIGNIFICANT LEVELS OF CORROSION WERE DISCOVERED ON THE MEMBRANE TAIL AND SPEAKER. THIS WOULD INDICATE THE DEVICE WAS INADEQUATELY STORED. FURTHER CORROSION WAS FOUND ON THE REAL TIME CLOCK CIRCUIT. THIS WOULD SUGGEST WATER INGRESS INTO THE DEVICE AND DAMAGE TO THE CIRCUITRY WOULD CAUSE THE AUTOMATIC SELF TESTS TO CEASE. THE INADEQUATE STORAGE OF THE DEVICE IS THE ROOT CAUSE OF THE PROBLEMS WITH THIS PAD. 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 THE STATUS INDICATOR WAS PERMANENTLY ILLUMINATED AND THE DEVICE WOULD NOT POWER-ON. 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
33088	HEARTSINE SAMARITAN 300P AND PAD PAK	AUTOMATED EXTERNAL DEFIBRILLATOR	MKJ	HEARTSINE TECHNOLOGIES, LTD	PAD

Patients

Seq	Age	Sex	Outcome	Treatment
1