FDA Adverse Event Malfunction Summary report: N

HEARTSINE SAMARITAN 300P AND PAD PAK

MDR report key: 4792588 · Received May 15, 2015

Report

Report Number: 3004123209-2015-00520
Event Type: Malfunction
Date Received: May 15, 2015
Date of Event: May 5, 2015
Report Date: June 19, 2015
Manufacturer: HEARTSINE TECHNOLOGIES, LTD
Product Code: MKJ
PMA / PMN Number: K041067
Removal / Correction Number: Z-0124-2013
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

ROUTINE TESTING CONFIRMED THAT THIS DEVICE WAS INSTALLED BY THE CUSTOMER IN MARCH 2010 AND PERFORMED TO SPECIFICATION, ALONGSIDE RANDOM MANUAL POWER ONS, UP TO THE 7TH DECEMBER 2014. A FRESH PAD-PAK WAS INSTALLED DURING THIS TIME. MULTIPLE MANUAL POWER UPS OF TEN MINUTES DURATION WERE OBSERVED IN THE DEVICE MEMORY BETWEEN 12TH DECEMBER 2014 AND 5TH FEBRUARY 2015. IT IS REASONABLE TO CONCLUDE THAT DEVICES RETURNED FOR THE REPORTED FAULT MAY BE ATTRIBUTED TO MEMBRANE FAILURE. THE TEN MINUTE TIME OUTS WOULD SUGGEST A FAILING MEMBRANE. THE FAULT WAS WITNESSED DURING THE INVESTIGATION. THE FAULT COULD NOT BE REPLICATED WITH A NEW MEMBRANE FITTED. THERE WAS SLIGHT VOLTAGE FLUCTUATION OBSERVED ON THE POGO-PINS, THIS DID NOT AFFECT THE ABILITY OF THE DEVICE TO DELIVER THERAPY. 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 PATIENT INVOLVED IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE THE PAD UNIT HAS SOLID GREEN STATUS INDICATOR LIGHT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
317976	HEARTSINE SAMARITAN 300P AND PAD PAK	AUTOMATED EXTERNAL DEFIBRILLATOR	MKJ	HEARTSINE TECHNOLOGIES, LTD	PAD

Patients

Seq	Age	Sex	Outcome	Treatment
1