MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC FR2+ DEFIB, ECG, GERMAN, EXCHANGE; AED

Model Number M3860A

Device Problem Erratic or Intermittent Display (1182)

Patient Problem Cardiac Arrest (1762)

Event Date 04/03/2023

Event Type  malfunction  

Event Description

It has been reported, that during a patient use event, the device's display became unreadable.There are no known consequences to the patient.

• Brand Name: FR2+ DEFIB, ECG, GERMAN, 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: 16718045
• MDR Text Key: 313135902
• Report Number: 3030677-2023-01506
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K051632
• 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

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: M3860A
• Device Catalogue Number: M3860-RFABD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 04/11/2023
• Supplement Dates Manufacturer Received: 04/03/2023
• Supplement Dates FDA Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1