MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC FR3 DEFIBRILLATOR TEXT, EU (T), EXCHANGE; AED

Model Number	861388
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the battery was drained and/or did not work.
Additional Manufacturer Narrative
16apr2025(c.Sides):updating the decision notes due to an additional information provided by the remote engineer that the battery was inoperative/out of power.This reporting decision is based on the criteria within wi0733.The reported issue/event impacts or potentially impacts therapy, which could cause or contribute to a death or serious injury if the malfunction were to recur.

• Brand Name: FR3 DEFIBRILLATOR TEXT, EU (T), EXCHANGE
• Common Device Name: AED
• 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: tanya deschmidt ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 21774882
• Report Number: 3030677-2025-001095
• Device Sequence Number: 8079564
• Product Code: MKJ
• UDI-Device Identifier: 00884838049987
• UDI-Public: (01)00884838049987
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P160028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2025

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: Other
• Device Model Number: 861388
• Device Catalogue Number: 453564402741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 04/07/2025; 04/07/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 04/08/2025; 04/16/2025
• Date Device Manufactured: 04/01/2015
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown