FDA Adverse Event Malfunction Summary report: N

BATTERY 14.8V, 6.3 AH LI-LON BATTERY

MDR report key: 3981297 · Received June 20, 2014

Report

Report Number
1218950-2014-03606
Event Type
Malfunction
Date Received
June 20, 2014
Report Date
May 30, 2014
Manufacturer
PHILIPS MEDICAL SYSTEMS
Product Code
MKJ
PMA / PMN Number
K031187
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

PR#: (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT THE BATTER WAS NOT DETECTED IN THE MRX OR CADEX BATTERY CHARGER AND WAS DEPLETED. THERE WAS NO REPORTED PT INVOLVEMENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
364316 BATTERY 14.8V, 6.3 AH LI-LON BATTERY MKJ PHILIPS MEDICAL SYSTEMS M3538A

Patients

Seq Age Sex Outcome Treatment
1