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

Model Number 861389

Device Problem Image Display Error/Artifact (1304)

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

Event Type  malfunction  

Event Description

It has been reported that the display of the device is not functioning as expected.

Manufacturer Narrative

Become aware date corrected to 28jul2021.

Manufacturer Narrative

Become aware date corrected to 28jul2021.

• Brand Name: FR3 DEFIB, ECG US 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: shannon decker ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 12293606
• MDR Text Key: 265576916
• Report Number: 3030677-2021-13443
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838049994
• UDI-Public: 00884838049994
• 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: Health Professional
• 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: 08/09/2021
• 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: 453564402771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/03/2021
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1