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

Model Number 861389

Device Problem Failure to Analyze Signal (1539)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Type  Death  

Event Description

The user stated that the patient experienced a cardiac arrest and is reporting the device did not analyze the patient's rhythm.The reported harm is classified as serious and therefore, the reported issue is deemed reportable.The patient did not survive.

Manufacturer Narrative

Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: HEARTSTART FR3
• Type of Device: AED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell everett hwy; bothell WA 98021
• MDR Report Key: 11232840
• MDR Text Key: 228829828
• Report Number: 3030677-2021-00166
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K130684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

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: 861389
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 80 YR