FDA Adverse Event Malfunction Summary report: N

HEARTSINE SAMARITAN 300P AND PAD PAK

MDR report key: 4792621 · Received May 15, 2015

Report

Report Number: 3004123209-2015-00504
Event Type: Malfunction
Date Received: May 15, 2015
Date of Event: April 29, 2015
Report Date: June 12, 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 Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

ROUTINE TESTING CONFIRMED THAT THIS DEVICE WAS INSTALLED BY THE CUSTOMER IN JANUARY 2011 AND PERFORMED TO SPECIFICATION UP TO THE 12TH JANUARY 2014. THE DATA OBTAINED FROM THE DEVICE SHOWED EVIDENCE THAT THE DEVICE WAS SWITCHING ITSELF ON AUTOMATICALLY, RESULTING IN MANUAL POWER-UPS OF 10 MINUTES IN DURATION OCCURRING BETWEEN (B)(6) 2014. THE PAD-PAK BECAME DEPLETED DURING THIS TIME. A FURTHER PAD-PAK WAS INSTALLED AND MULTIPLE MANUAL POWER UPS OF 10 MINUTES DURATION WERE AGAIN RECORDED IN THE HISTORY LOG BETWEEN THE (B)(6) 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. 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. (B)(4).

Description of Event or Problem · 1

THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THIS DEVICE WAS MALFUNCTIONED, AS THE DEVICE SWITCHES ON AUTOMATICALLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
317983	HEARTSINE SAMARITAN 300P AND PAD PAK	AUTOMATED EXTERNAL DEFIBRILLATOR	MKJ	HEARTSINE TECHNOLOGIES, LTD	PAD

Patients

Seq	Age	Sex	Outcome	Treatment
1