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

Model Number	M3538A
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the battery fails calibration by only being able to charge to 53%.There was no patient involvement.
Event or Problem Description
It was reported to philips that the battery fails calibration by only being able to charge to 53%.

• 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: 11864499
• Report Number: 3030677-2021-11646
• Device Sequence Number: 16863641
• 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: user facility
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Distributor Facility Aware Date: 04/26/2021
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1