MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC FR2+ DEFIB, ECG, US ENGLISH, EXCHANGE; AED

Model Number	861458
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 that the device is failing self-test.

• Brand Name: FR2+ DEFIB, ECG, US ENGLISH, 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: dana tackett ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 13260863
• Report Number: 3030677-2022-00274
• Device Sequence Number: 1519018
• Product Code: MKJ
• UDI-Device Identifier: 00884838050389
• UDI-Public: 00884838050389
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K051632
• 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

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: Health Professional
• Device Model Number: 861458
• Device Catalogue Number: M3860-RFABA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2001
• 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
• Patient Sex: Unknown