UNIPOWER BATTERY B10544

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-15 for UNIPOWER BATTERY B10544 manufactured by Unipower Corporation.

Event Text Entries

[21697611] In four cases the facility is aware of, replacement batteries for zoll pd-1200 defibrillators overheated and failed. In one case, the heat melted the wire insulation resulting in a short circuit of the battery. Batteries failed in less than two months from date of the installation. Heat from the batteries was sufficient to melt and deform the battery door, requiring replacement. The problem was discovered when the defibrillators failed the daily functional test. In addition to the defibrillator failing to function, this is a possible fire hazard.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 562237
• MDR Report Key: 562237
• Date Received: 2004-12-15
• Date of Report: 2004-12-15
• Date of Event: 2004-12-14
• Report Date: 2004-12-15
• Date Reported to FDA: 2004-12-15
• Date Added to Maude: 2005-01-03
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: UNIPOWER BATTERY
• Generic Name: BATTERY
• Product Code: FCP
• Date Received: 2004-12-15
• Returned To Mfg: 2004-12-14
• Model Number: B10544
• Catalog Number: B10544
• Lot Number: SO 0199135
• ID Number: *
• Device Availability: Y
• Device Age: 2 MO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 551949
• Manufacturer: UNIPOWER CORPORATION
• Manufacturer Address: 1216 WEST 96TH STREET MINNEAPOLIS MN 55431 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-12-15