MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC FRX DEFIBRILLATOR, JAPANESE, EXCHANGE; 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
The authorized service personnel (asp) advised the customer to remove the device from service and a replacement device will be sent under warranty.The device is not available for investigation due to a logistical limitation that is preventing the return of the device.When the limitation has been resolved and the device is returned to philips, the complaint shall be reopened to document further investigation.Based on the information available there is insufficient information to confirm the reported problem.Based on the information available and results of additional analysis, no further action is necessary at this time the asp advised the customer to remove the device from service and a replacement device will be sent under warranty.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: FRX DEFIBRILLATOR, JAPANESE, EXCHANGE
• 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: 17990571
• Report Number: 3030677-2023-04214
• Device Sequence Number: 15268830
• Product Code: MKJ
• UDI-Device Identifier: 00884838006560
• UDI-Public: 00884838006560
• 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: 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: 453564087081
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2011
• 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