MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC FRX (W B) DEFIB, US ENGLISH, EXCHG; AED

Model Number	861304
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 to philips the customer called and stated that the aed is not working properly.The aed does not initiate a self-test when the battery is inserted.When the battery is inserted, there is a single chirp and no prompts.When the blue i button is pressed the aed states ready for use.This is outside of the normal self test operation of the aed.The aed is to be exchanged at zero cost to the customer under ib warranty exchange.

• Brand Name: FRX (W B) DEFIB, US ENGLISH, EXCHG
• 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: 17886662
• Report Number: 3030677-2023-03967
• Device Sequence Number: 17891204
• Product Code: MKJ
• UDI-Device Identifier: 00884838006560
• UDI-Public: 00884838006560
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 861304
• Device Catalogue Number: 453564595641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown