MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC FR3 DEFIB, ECG UK ENGLISH (T) EXCHANGE; AED

Model Number 861389

Device Problem Failure of Device to Self-Test (2937)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It has been reported that the device is failing self-test.

• Brand Name: FR3 DEFIB, ECG UK ENGLISH (T) EXCHANGE
• 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: 19215162
• MDR Text Key: 341421134
• Report Number: 3030677-2024-01565
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838049994
• UDI-Public: 00884838049994
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P160028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• 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
• Device Operator: Other
• Device Model Number: 861389
• Device Catalogue Number: 453564405921
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/24/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1