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

Model Number 861290

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Injury (2348)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted after philips obtains more information concerning this event.Patient information has been requested.

Event Description

It was reported to philips the device had a malfunction error.The device was reported to be in use on a patient, possibly causing a delay in life threatening therapy/ treatment and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.Additional details have been requested.

Manufacturer Narrative

Updated from serious injury to non adverse event.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.

Event Description

It was reported to philips the device had a malfunction error.This report has been updated from a serious injury to a non adverse event as additional information received clarified there was no patient involvement.(updated).

• Brand Name: HEARTSTART XL+ DEFIBRILLATOR/MONITOR
• Type of Device: ALS DEFIBRILLATOR MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10979722
• MDR Text Key: 220634767
• Report Number: 1218950-2020-07640
• Device Sequence Number: 1
• Product Code: MKJ
• 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: 11/24/2020

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: 11/24/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 11/24/2020
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1