MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC FR2+ DEFIB, TEXT, FRENCH, EXCHANGE; AED

Model Number	861459
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	04/10/2022
Type of Reportable Event	Death
Event or Problem Description
The user is disagreeing with the "no shock advised" notification given by the device during a patient use event.The emergency response team arrived n scene and with their own equipment, delivered 6 shocks.The patient did not survive.

• Brand Name: FR2+ DEFIB, TEXT, FRENCH, 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: 14686266
• Report Number: 3030677-2022-03000
• Device Sequence Number: 5410786
• Product Code: MKJ
• UDI-Device Identifier: 00884838050396
• UDI-Public: 00884838050396
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,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: 861459
• Device Catalogue Number: M3861-RFABF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 09/07/2022; 10/31/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 09/07/2022; 10/31/2022
• Date Device Manufactured: 03/01/2004
• 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
• Patient Sex: Unknown