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

Model Number 861304

Device Problem Failure of Device to Self-Test (2937)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It has been reported that the device is failing self-test.

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 FRX
• Type of Device: AED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell everett hwy; bothell WA 98021
• MDR Report Key: 10678610
• MDR Text Key: 213256793
• Report Number: 3030677-2020-01676
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838006560
• UDI-Public: (01)00884838006560
• Combination Product (y/n): N
• PMA/PMN Number: 050004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2020

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: Other
• Device Model Number: 861304
• Device Catalogue Number: 861304
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 10/09/2020; 10/09/2020
• Supplement Dates FDA Received: 11/02/2020; 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1