MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC BATTERY 14.8V, 6.3 AH LI-ION BATTERY

Model Number	M3538A
Medical Device Problem Codes	Failure to Charge (1085); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported to philips that the battery fails to charge.
Additional Manufacturer Narrative
Failure analysis: the battery was returned for failure analysis.The battery, received in a low charge, was able to charge (in both mrx heartstart unit and cadex c7200 battery analyzer), calibrate, and seemed to operate normally.The battery was received with indication that it needed to be calibrated.Battery calibration was successfully performed and resulted in a battery capacity of 88%.Except from the physical damage to the fuel gauge button there is no fault found with this battery functionality wise.The battery failure analysis found the battery only needed calibration.The battery did not malfunction needing only calibration.The customer to be sent replacement battery.No further action at this time.

• Brand Name: BATTERY 14.8V, 6.3 AH LI-ION BATTERY
• Common Device Name: BATTERY
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 12006270
• Report Number: 3030677-2021-12237
• Device Sequence Number: 11527872
• Product Code: MKJ
• UDI-Device Identifier: 00884838002791
• UDI-Public: 00884838002791
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M3538A
• Device Catalogue Number: M3538A
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/20/2021
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1