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

Model Number 861290

Device Problem Device Sensing Problem (2917)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported to philips that the ecg waveform was undetectable.The patient expired.Additional information has been requested.

Event Description

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.It was reported to philips that the ecg waveform was undetectable.The patient expired.The electronic event file and patient waveforms were reviewed by philips clinicians.On (b)(6) 2020 the device was powered on into the monitor mode, then briefly to manual mode, then back to monitor mode.Ecg leads were placed at 0:59 (seconds) elapsed time (et).The ecg appeared as very noisy with a wide/thickened baseline.The appearance of the ecg waveform was consistent with some sort of interference.An asystole alarm was followed by several ¿learning ecg¿ messages, then a ¿cannot analyze ecg¿ message.The users cycled the power off and then on.Vfib/vtach alarms occurred and continued ¿cannot analyze¿ and ¿learning ecg¿ messages until the device was powered off at 9:17 et.The users did not try a different ecg lead to monitor.It is unknown how the users planned to defibrillate the patient as no defibrillator pads were in place to view the waveform and external paddles were not used to look at the ecg waveform.Defibrillation can be performed via pads in the aed mode, and by pads or paddles in the manual mode.The users switched to a different model of defibrillator and reportedly delivered 8 shocks.The involved patient died.The patient did not have any type of implanted device, pacemaker or tens unit.Philips was unable to obtain any information about other equipment that may have been in use in the patient room at the time of this event.The dfm100 instructions for use (ifu) edition1.7 453564403811 describes the function of the lead select button which allows the user to scroll through the available ecg waves to change the wave being displayed, if desired.Chapter 5 of the ifu describes how the user can achieve optimal ecg waveform monitoring.Page27: changes the ecg lead in wave sector 1.Pressing this button cycles through the available ecg waves, changing the displayed wave and label.The list of available ecg waves is based on the connected lead set and your device configuration, including pads, if the corresponding cable is connected.See ¿lead selection¿ on page 53.Ifu illustrates "cannot analyze ecg" situation in ecg monitoring and troubleshooting chapter, guides the user to check ecg signal quality.If necessary, improve lead position or reduce patient movement.The customer's reported problem was unable to be reproduced.The device successfully passed all required testing.The device remains at the customer site and no further evaluation is required at this time.

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: 10984934
• MDR Text Key: 220713356
• Report Number: 1218950-2020-07671
• 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: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• 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
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Weight: 40