MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART FR3; AED

Model Number 861389

Device Problems Failure to Analyze Signal (1539); Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Insufficient Information (4580)

Event Type  malfunction  

Event Description

The user is questioning the functionality of the device during a patient use event.The patient survived.

Event Description

The use is questioning the functionality of the device during a patient use event.The patient survived.

• Brand Name: HEARTSTART FR3
• Type of Device: AED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell everett hwy; bothell WA 98021
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 22100 bothell everett hwy; bothell WA 98021
• Manufacturer Contact: shannon decker ; 22100 bothell everett hwy; bothell, WA 98021
• MDR Report Key: 10846140
• MDR Text Key: 217924524
• Report Number: 3030677-2020-01865
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838049994
• UDI-Public: (01)00884838049994
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 861389
• Device Catalogue Number: 861389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 68 KG