MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEART START XL; DEFIBRILLATOR

Model Number M4735A

Device Problems Failure to Analyze Signal (1539); Defibrillation/Stimulation Problem (1573)

Patient Problem Atrial Fibrillation (1729)

Event Type  malfunction  

Event Description

It was reported to philips that the heartstart xl monitor / defibrillator did not provide synchronized cardioversion therapy to a patient experiencing atrial fibrillation.Patient outcome is unknown at this time.Further information has been requested.

Manufacturer Narrative

This complaint was updated from serious injury to non adverse event based on clinical review during investigation that there was no harm to the patient.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 that the heartstart xl monitor / defibrillator did not provide synchronized cardioversion therapy to a patient experiencing atrial fibrillation.This complaint was updated from serious injury to non adverse event based on clinical review during investigation that there was no harm to the patient.On (b)(6) 2019 this heartstart xl defibrillator was used for synchronized cardioversion via defib pads on a patient with atrial fibrillation and a heartrate of 140 beats per minute (bpm).The brand of defib pads was not reported.The users attempted 2 shocks at 100j and reported that "no shock was triggered after charging the device".A third attempt at 100j had the same result.The users checked the electrodes, powered the device off then on, and tried a 4th time to deliver 100j but with the same result.They then switched to a different defibrillator to treat the patient.No ecg strips or case events files were submitted to philips for evaluation.The customer¿s biomedical engineer removed and tested the device, including an ecg test, and found it to be fully functional.The device was evaluated at the philips bench.The reported problem could not be replicated.The device passed all performance tests.Philips is unable to determine the cause of the reported symptom as the symptom could not be reproduced and the device passed all testing.Ecg strips from the event were not provided and could not be part of the analysis.The device was returned to the customer from the philips bench.The device remains in use at the customer site.The information gathered for this report does not provide evidence of a systemic, design, or labeling problem.

• Brand Name: HEART START XL
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 9501447
• MDR Text Key: 172212039
• Report Number: 1218950-2019-09610
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K001725
• 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: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M4735A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 50 YR