MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART XL+ DEFIBRILLATOR/MONITOR

Model Number 861290

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problems Arrhythmia (1721); Death (1802)

Event Date 02/14/2021

Event Type  Death  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported to philips that the device failed to deliver a shock to a patient and the patient passed away.It was later noted by the customer that the event data showed a "pads shorted" message following the event.

Event Description

It was reported to philips that the device failed to deliver a shock to a patient and the patient passed away.It was later noted by the customer that the event data showed a "pads shorted" message following the event.

• Brand Name: HEARTSTART XL+ DEFIBRILLATOR/MONITOR
• Type of Device: DEFIBRILLATOR
• 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: bethany glynn ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 11407728
• MDR Text Key: 234548450
• Report Number: 3030677-2021-10009
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838023680
• UDI-Public: 00884838023680
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 861290
• Device Catalogue Number: 861290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/14/2021
• Initial Date Manufacturer Received: 02/14/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 07/23/2021
• Supplement Dates FDA Received: 08/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 42 YR