HEARTSINE SAMARITAN 300P AND PAD PAK

Report

• Report Number: 3004123209-2012-00854
• Event Type: Malfunction
• Date Received: December 19, 2012
• Date of Event: November 27, 2009
• Report Date: December 17, 2012
• 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

THERE ARE (B)(4) RECORDED EVENTS ON THE RETURNED PAD DEVICE. THE DEVICE APPEARS TO HAVE FUNCTIONED AS EXPECTED UNTIL (B)(6) 2009. AFTER THIS DATE, THERE ARE MULTIPLE EVENTS ON THE SAME DAY WHICH SHOULD INDICATE THE DEVICE WAS SWITCHING ITSELF ON AUTOMATICALLY. THE PROBLEM WITH THE DEVICE WAS ATTRIBUTED TO A FAULT IN THE MEMBRANE. 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 IT WAS SWITCHING ITSELF ON AUTOMATICALLY. A DEVICE SWITCHING ITSELF ON AUTOMATICALLY, IF LEFT UNDETECTED COULD RESULT IN THE BATTERY BECOMING DEPLETED.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• No Patient Involvement

Product problems · 1

• Power Problem

Source type · 1

• Distributor

Type of report · 1

• Initial submission