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

Model Number 861389

Device Problem Inaudible or Unclear Audible Prompt/Feedback (2283)

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

Event Type  malfunction  

Event Description

It has been reported that device speakers are not functioning correctly.

• 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
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: dana tackett ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 12416098
• MDR Text Key: 270289837
• Report Number: 3030677-2021-14090
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838049994
• UDI-Public: 00884838049994
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 861389
• Device Catalogue Number: 453564155061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/31/2021
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• Is the Device Single Use?: No
• Patient Sequence Number: 1