MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC FR3 DEFIB, ECG, JAPANESE, EXCHANGE; AED

Model Number 861389

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

Updated awareness date.

• Brand Name: FR3 DEFIB, ECG, JAPANESE, EXCHANGE
• Type of Device: AED
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 11423633
• MDR Text Key: 235039051
• Report Number: 3030677-2021-10101
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838049994
• UDI-Public: 00884838049994
• Combination Product (y/n): N
• PMA/PMN Number: P160028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 861389
• Device Catalogue Number: 453564155061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Distributor Facility Aware Date: 04/19/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 05/19/2021; 10/14/2021
• Supplement Dates FDA Received: 04/22/2021; 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1