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

Model Number	M3860-RFABA
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Unspecified Heart Problem (4454)
Date of Event	03/03/2023
Type of Reportable Event	Death
Event or Problem Description
It has been reported tp philips, the device has a red light, impossible to deliver shock.
Event or Problem Description
New information confirms the patient did not survive.
Additional Manufacturer Narrative
New information received confirms patient did not survive.

• 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: marie-therese assaf ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 16571622
• Report Number: 3030677-2023-01173
• Device Sequence Number: 11941712
• Product Code: MKJ
• UDI-Device Identifier: 00884838050389
• UDI-Public: 00884838050389
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K003565
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M3860-RFABA
• Device Catalogue Number: M3860-RFABA
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 03/23/2023; 05/03/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 03/27/2023; 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Death; Life Threatening
• Patient Sex: Unknown