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

Model Number 861304

Device Problem Failure to Discharge (1169)

Patient Problem Unspecified Heart Problem (4454)

Event Date 11/14/2022

Event Type  Death  

Event Description

Edward called for assistance with downloading event data from the frx.Upon reviewing the data, it was noted that it was expected to see a shock delivered in the report.No such shock was noted in the report.With this discrepancy, it was advised to have the device psdr data reviewed to confirm device activity during the last-use event.Edward was instructed on how to obtain the.Mic file, so he can send via email for review.

Manufacturer Narrative

Updating type of complaint to death based on subsequent review of the case.Health impact code: death c28554.

Event Description

(b)(6) called for assistance with downloading event data from the frx.Upon reviewing the data, it was noted that it was expected to see a shock delivered in the report.No such shock was noted in the report.With this discrepancy, it was advised to have the device psdr data reviewed to confirm device activity during the last-use event.(b)(6) was instructed on how to obtain the.Mic file, so he can send via email for review.It has been confirmed the patient did not survive.

• Brand Name: FRX (W B) DEFIB, US 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: tanya deschmidt ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 15973713
• MDR Text Key: 305411475
• Report Number: 3030677-2022-05617
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838080768
• UDI-Public: 00884838080768
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• 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: 453564595641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death