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

Model Number 861290

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Code Available (3191)

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A customer reported that the internal paddles failed while in use on a patient.Additional details have been requested from the customer.This event will be submitted for reporting as a serious injury because it was in use on a patient.

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.

Event Description

A customer reported that the internal paddles failed while in use on a patient.This event will be submitted for reporting as a serious injury because it was in use on a patient.There was no adverse event to patient or user.Additional information regarding patient procedure and patient details was requested but not available.A philips field service engineer (fse) evaluated the device.The reported issue was confirmed and traced to a faulty internal paddle set.There were no patient event files or ecg monitoring strips from the event available for review.The fse replaced the internal paddle set.The device passed all performance assurance tests and was placed back into use with the customer.

• 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: 9511786
• MDR Text Key: 172586319
• Report Number: 1218950-2019-09676
• 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: 12/19/2019

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: 12/19/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 12/19/2019
• Supplement Dates FDA Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening