MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC FRX (W B) DEFIB, UK ENGLISH, EXCHG; AED

Model Number 861304

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Death (1802)

Event Date 02/24/2021

Event Type  Death  

Event Description

It has been reported that while the device was in use on a patient, it did not deliver a shock.The patient did not survive.

• Brand Name: FRX (W B) DEFIB, UK ENGLISH, EXCHG
• Type of Device: 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: shannon decker ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 11399966
• MDR Text Key: 234288178
• Report Number: 3030677-2021-10044
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838080768
• UDI-Public: 00884838080768
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P180028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 861304
• Device Catalogue Number: 453564595651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/25/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death