MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART FRX DEFIBRILLATOR; 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 that the device is failing self-test.
Additional Manufacturer Narrative
Available details indicate that the device failed the self-test.Bit (battery insertion test) was performed, the issue persists.The device issued the error message "remove and re-insert battery," followed by single chirps.Replacement device sent to the customer to resolve the issue.The customer was provided a replacement device to resolve the issue and we are expecting the return of the exchanged device.Upon receipt at philips the device will be evaluated, and the complaint will be reopened.Based on the information available and the testing conducted, the cause of the reported problem was faulty device.The reported problem was confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.Available details indicate that the device failed the self-test.Bit (battery insertion test) was performed, the issue persists.The device issued the error message "remove and re-insert battery," followed by single chirps.Replacement device sent to the customer to resolve the issue.The customer was provided a replacement device to resolve the issue and we are expecting the return of the exchanged device.Upon receipt at philips the device will be evaluated, and the complaint will be reopened.Based on the information available and the testing conducted, the cause of the reported problem was faulty device.The reported problem was confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.

• Brand Name: HEARTSTART FRX DEFIBRILLATOR
• 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: 18150178
• Report Number: 3030677-2023-04545
• Device Sequence Number: 12415418
• Product Code: MKJ
• UDI-Device Identifier: 00884838006560
• UDI-Public: 00884838006560
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: User Facility
• 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: 453564013771
• 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: 11/14/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2016
• 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