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

Model Number 861290

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is completed.

Event Description

A customer reported that the device did not deliver a shock.The device was in use on a patient at the time of the alleged malfunction.The patient survived, but there was an adverse event as a result of the alleged malfunction.Additional information has been requested from the customer.

Event Description

A customer reported that the device did not deliver a shock on an arrested heart patient during a critical case.Another defibrillator was used to treat the patient and the patient survived.We are considering this event to be a serious injury based on the report that life-threatening treatment was interrupted requiring the use of another defibrillator.The heartstart xl+ defibrillator was evaluated by the customer who stated the operational check is done periodically as recommended and the device was not indicating any errors on the rfu indicator.The device remains with the customer and was returned to use.Ecg monitoring strips and case event files were unable to be provided to philips for review.The hardware and software error logs were provided to philips for review.A philips product support engineer determined there was no indication of parts failures that would cause the heartstart xl+ to be unable to deliver a shock according to its specification.The cause of why this device may not have been able to deliver a shock, therefore, could not be determined.

Manufacturer Narrative

H.10.Patient information was requested but not available.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.H3 other text : the customer evaluated the device and provided logs to philips for review.

• 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: 9674750
• MDR Text Key: 177931321
• Report Number: 1218950-2020-00893
• 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: 01/31/2020

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: 01/28/2020
• Initial Date FDA Received: 02/05/2020
• Supplement Dates Manufacturer Received: 01/28/2020
• Supplement Dates FDA Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening