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

Model Number 861389

Device Problem Failure to Analyze Signal (1539)

Patient Problem Cardiac Arrest (1762)

Event Date 01/17/2024

Event Type  Injury  

Event Description

It has been reported that the device continuously gave the "analyzing" voice prompt during a patient use event.The patient outcome is unknown.

• 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: tanya deschmidt ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 19211982
• MDR Text Key: 341364606
• Report Number: 3030677-2024-01563
• Device Sequence Number: 1
• Product Code: MKJ
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 861389
• Device Catalogue Number: 453564402771
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other