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

Model Number	HEARTSTART FR3
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	12/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The device was reported to be in use on a patient, causing a delay in life saving therapy and will be considered a serious injury.

• Brand Name: HEARTSTART
• 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: syed zaheer ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 24897319
• Report Number: 3030677-2026-100442
• Device Sequence Number: 8805968
• Product Code: MKJ
• UDI-Device Identifier: 00884838049994
• UDI-Public: (01)00884838049994
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

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: HEARTSTART FR3
• Device Catalogue Number: 861389
• 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: 04/10/2026
• Supplement Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2014
• 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: Required Intervention
• Patient Sex: Unknown