MAUDE Adverse Event Report: Philips North America LLC PHILIPS HeartStart FRx; AED

Model Number	Heartstart FRx
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/23/2026
Type of Reportable Event	Death
Event or Problem Description
Philips received a complaint on the heartstart frx indicating that a patient was found unresponsive while sleeping and they were unable to locate a pulse.When the pads were applied, the device began chirping and a second device had to be obtained.The outcome was a patient death.

• Brand Name: PHILIPS HeartStart FRx
• 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: maria heiling ; 22100 bothell everett highway; bothell, WA 98021 ; +1(909)570-3538
• MDR Report Key: 50926006
• Report Number: 3030677-2026-101035
• Device Sequence Number: 5804548
• Product Code: MKJ
• UDI-Device Identifier: 00884838080768
• UDI-Public: (01)00884838080768
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P180028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: Heartstart FRx
• Device Catalogue Number: 861304
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 10/11/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 58 YR
• Patient Sex: Female