FDA Adverse Event Malfunction Summary report: N

BATTERY 14.8V, 6.3 AH LI-ION BATTERY

MDR report key: 4230971 · Received October 15, 2014

Report

Report Number
1218950-2014-06197
Event Type
Malfunction
Date Received
October 15, 2014
Report Date
September 23, 2014
Manufacturer
PHILIPS MEDICAL SYSTEMS
Product Code
MJK
PMA / PMN Number
K031187
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
SP
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

PR#: (B)(4).

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT THEIR BATTERY WAS DAMAGED. THERE WAS NO REPORTED PT INVOLVEMENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
652625 BATTERY 14.8V, 6.3 AH LI-ION BATTERY MJK PHILIPS MEDICAL SYSTEMS M3538A

Patients

Seq Age Sex Outcome Treatment
1