MAUDE Adverse Event Report: Philips North America LLC HeartStart FR3; AED

Model Number	861389
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	07/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a patient use event, the user is stating the device advised and delivered a shock on a conscious patient.The patient died 24 hours after the patient use event.
Event or Problem Description
During a patient use event, the user is stating the device advised and delivered a shock on a conscious patient.There is no known harm to the patient.
Additional Manufacturer Narrative
Updated case to reflect that the patient did not survive.Updated reporter information.Updated device information.

• Brand Name: 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: maria heiling ; 22100 bothell everett highway; bothell, WA 98021 ; +1(909)570-3538
• MDR Report Key: 50134117
• Report Number: 3030677-2026-100829
• Device Sequence Number: 10513971
• Product Code: MKJ
• UDI-Device Identifier: 00884838049987
• UDI-Public: (01)00884838049987
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2026

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: 861389
• Device Catalogue Number: 861388
• Device Lot Number: M02454-2229
• 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: 07/31/2026
• Supplement Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Other
• Patient Sex: Unknown