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

Model Number 861290

Device Problem Loss of Power (1475)

Patient Problem No Code Available (3191)

Event Date 10/07/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to philips that the heartstart xl+ monitor / defibrillator lost power during monitoring.Philips is considering this event to be a serious injury because it is unknown if the patient experienced an adverse event, the outcome of the event is unknown, and it is unknown if the treatment was interrupted.Additional information has been requested.

Event Description

It was reported to philips that the heartstart xl+ monitor / defibrillator lost power during preparation for cardioversion.The patient was in unstable svt (supraventricular tachycardia).The defibrillator was attached by both leads and pads.The user decided to give adenosine first using defibrillator as monitor (still connected).The defibrillator powered off and restarted 14 seconds later.The patient's rhythm was converted after the administration of the adenosine but there was no complete ecg recording of the waveforms during this period.No electrical therapy was required.This report has been updated from a serious injury to a non adverse event as additional information received clarified the treatment was a stable sync monitoring/procedure which was not life-threatening.The ecg waveform was reviewed and showed that the patient was in a supraventricular tachycardia (svt) at 170-180 beats per minute (bpm).At 7:35 elapsed time (et) the patient's heart rate began to decrease and at 7:43 et the device underwent a restart.Ecg monitoring resumed 14 seconds later at 7:57 et and the patient's heart rate was in 80-90 bpm range for the remainder of the event.The event files show that when the device restarted and resumed monitoring there was a "device restarted due to error" message.The monitoring continued for approximately 22 more minutes before the device was powered off.The device restarted during the monitoring of the patient ecg rhythm during administration of adenosine resulting in an interruption of the monitoring.There was no attempted cardioversion during this event.A philips authorized service provider evaluated the device and was unable to duplicate the issue.The device hardware logs were reviewed by the philips product support engineer and there were no entries pertaining to this event.No parts were replaced.The device passed all performance assurance tests and was placed back into use with the customer.Philips was unable to determine the cause of the reported reboot.(b)(6) will be implemented on this device as it addresses unexpected reboot issues.

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: ALS DEFIBRILLATOR MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 9255849
• MDR Text Key: 164288011
• Report Number: 1218950-2019-08275
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

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: 10/24/2019
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: 10/24/2019
• Supplement Dates FDA Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0608-2020
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening