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

Model Number 861290

Device Problem Failure to Discharge (1169)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 08/22/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A customer reported that the device did not discharge during an emergency resuscitation attempt.We are considering this to be a serious injury because it is not known if the patient procedure was life-threatening nor if the treatment was interrupted.Additional information has been requested from the customer.

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 device did not discharge during an emergency resuscitation attempt.The device was report to be in use on a patient, causing a delay in therapy/treatment and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.The customer biomedical engineer reported that the device was evaluated after the event, and found the pads and paddles "in good state." the customer biomedical engineer tested the discharge function and found it to be faulty.The biomedical engineer determined that the faulty discharge was caused by residual gel on the paddles and sockets.The device was cleaned, disinfected, and tested again.The device passed all testing.No ecg strips or case events files were provided to philips for evaluation.The customer biomedical engineer analyzed the event files in detail, and summarized the device behavior during the event as follows: ¿the aforementioned demonstrates that the equipment started to be used at 11:27:06 until 11:39, showing a time lapse of 10 minutes when it is observed that the operator(s) make various modifications in the programming of the defibrillation and ecg reading modes (paddles or derivatives).In addition, the history indicates that various automatic disarmings occurred that the equipment generates for safety reasons, as the adjusted power charge lasts more than 30 seconds without the staff carrying out the corresponding discharge.There is no evidence in the history of any fault that the equipment could have shown in the procedure.¿ philips requested but did not receive additional information related to the event.The device remains in service at the customer site.The customer biomedical engineer recommended that the device be tested daily by hospital staff.The information gathered for this report does not provide evidence of a systemic, design, or labeling problem.No further investigation or action is warranted.

• 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: 9418341
• MDR Text Key: 169299438
• Report Number: 1218950-2019-09218
• 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: 11/06/2019

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: 11/06/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 11/06/2019
• Supplement Dates FDA Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1