MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART XL+ DEFIBRILLATOR/MONITOR; XL+ DEFIBRILLATOR

Model Number 861290

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is completed.

Event Description

It was reported to philips that the device not shock delivery during a cardioversion.The device was reported to be in use on a patient, causing a delay in therapy/ treatment and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.The efficia dfm100 defibrillator, model # 866199, is substantially similar to the heartstart xl+ defibrillator (model # 861290) and will be reported in the united states under device model # 861290.

Event Description

It was reported to philips that the device not shock delivery during a cardioversion.There was no patient involvement.The efficia dfm100 defibrillator, model# 866199, is substantially similar to the heartstart xl+ defibrillator (model # 861290) and will be reported in the united states under device model # 861290.

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 XL+ DEFIBRILLATOR/MONITOR
• Type of Device: XL+ DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10878946
• MDR Text Key: 217632146
• Report Number: 1218950-2020-07089
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838023680
• UDI-Public: (01)00884838023680
• Combination Product (y/n): N
• PMA/PMN Number: K110825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 11/18/2020
• Supplement Dates FDA Received: 04/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1