MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART FRX DEFIBRILLATOR; AED

Model Number 861304

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Cardiac Arrest (1762)

Event Date 08/09/2021

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It has been reported that the device did not shock during a patient use event and instead began analyzing again.The patient did not survive.

Manufacturer Narrative

Updated, awareness date.

Event Description

It has been reported, that the device did not shock, during a patient use event.And instead began analyzing again.The patient did not survive.

• Brand Name: HEARTSTART FRX DEFIBRILLATOR
• Type of Device: AED
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 12316143
• MDR Text Key: 266308276
• Report Number: 3030677-2021-13592
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838080768
• UDI-Public: 00884838080768
• Combination Product (y/n): N
• PMA/PMN Number: P180028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 861304
• Device Catalogue Number: 453564013771
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/09/2021
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death