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

Model Number	M3538A
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the battery fails to charge.There was no patient involvement.
Additional Manufacturer Narrative
Complaint evaluation: the customer requested that a philips field service engineer (fse) be dispatched to the customer site.The reported issue was confirmed and traced to a faulty battery.The customer is sending battery back to philips for analysis.Customer resolution and conclusion: upon conclusion of the evaluation, it was determined that this was a malfunction of the battery.The battery will be replaced under the warranty.No further evaluation is required at this time.

• Brand Name: BATTERY 14.8V, 6.3 AH LI-ION BATTERY
• Common Device Name: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: dana tackett ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 12569038
• Report Number: 3030677-2021-14658
• Device Sequence Number: 14460974
• Product Code: MKJ
• UDI-Device Identifier: 00884838002791
• UDI-Public: 00884838002791
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K051134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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
• Device Lot Number: 20043-0104-P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 03/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown