MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PHILIPS HEARTSTART FR3; AED

Model Number	861389
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported that the device is failing self-test.
Additional Manufacturer Narrative
Updated conclusion code, evaluation method code, evaluation results code, and component code.

• Brand Name: PHILIPS HEARTSTART FR3
• 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: 22588948
• Report Number: 3030677-2025-001700
• Device Sequence Number: 9179818
• Product Code: MKJ
• UDI-Device Identifier: 00884838049994
• UDI-Public: (01)00884838049994
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2025

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: 861389
• Device Catalogue Number: 453564402781
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 08/06/2025; 10/28/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/11/2025; 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2016
• 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