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

Model Number 861290

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported to philips that the monitor screen is dark and it doesn't show waves.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: 11170805
• MDR Text Key: 228172409
• Report Number: 1218950-2021-00271
• 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: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 01/05/2021
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 01/05/2021
• Supplement Dates FDA Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1