FDA Adverse Event Malfunction Summary report: N

HEARTSINE SAMARITAN 300P AND PAD PAK

MDR report key: 2932498 · Received January 23, 2013

Report

Report Number: 3004123209-2013-00038
Event Type: Malfunction
Date Received: January 23, 2013
Date of Event: December 13, 2009
Report Date: January 4, 2013
Manufacturer: HEARTSINE TECHNOLOGIES, LTD, CANBERRA HOUSE
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 RETURNED PAD DEVICE WAS INSTALLED ON (B)(6) 2008 AND PERFORMS AS EXPECTED UNTIL (B)(6) 2009. THE DEVICE FAILS A SELF TEST ON THE (B)(6) 2009 DUE TO A LOW BATTERY. THE TEMPERATURE AT THIS TIME WAS -3.2 DEGREE C INDICATING THE DEVICE WAS BEING STORED IN AN INADEQUATE LOCATION. THE BATTERY PERFORMANCE CAN BE ADVERSELY AFFECTED BY VERY LOW TEMPERATURES. AFTER THE FAILED SELF TEST ON (B)(6) 2009, IT APPEARS TEH DEVICE WAS LEFT IN FAULT MODE. THIS WOULD HAVE THE EFFECT OF DEPLETING THE PAD-PAK TO THE POINT WHERE IT HAD INSUFFICIENT CAPACITY TO POWER THE STATUS INDICATOR OR ENABLE THE DEVICE TO BE SWITCHED ON. 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 PT INVOLVED IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE THE STATUS INDICATOR WAS NOT FLASHING, THE DEVICE WAS EMITTING A LOW BATTERY WARNING AND WON'T 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
33373	HEARTSINE SAMARITAN 300P AND PAD PAK	AUTOMATED EXTERNAL DEFIBRILLATOR	MKJ	HEARTSINE TECHNOLOGIES, LTD, CANBERRA HOUSE	PAD

Patients

Seq	Age	Sex	Outcome	Treatment
1