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

Model Number	HEARTSTART FRX
Medical Device Problem Code	No Visual Prompts/Feedback (4021)
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 status indicator is not working.
Additional Manufacturer Narrative
Bad in mfr report number 3030677-2025-001353 should be 13may2025.
Additional Manufacturer Narrative
Updated method code grid.
Additional Manufacturer Narrative
Updated the udi to (b)(4).

• 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: tanya deschmidt ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 22045165
• Report Number: 3030677-2025-001353
• Device Sequence Number: 8899311
• Product Code: MKJ
• UDI-Device Identifier: 00884838006560
• UDI-Public: (01)00884838006560
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/20/2025

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: HEARTSTART FRX
• Device Catalogue Number: 861304
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 06/05/2025; 07/30/2025; 08/12/2025; 08/19/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/05/2025; 07/30/2025; 08/12/2025; 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2015
• 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