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

Model Number 861290

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to philips the device failed to deliver a shock.After the user checked connections, the device again did not shock.There was a need to maintain basic and advanced life support until the user could retrieve another device which delayed defibrillation for the patient.The device was reported to be in use on a patient, causing a delay in life threatening therapy/treatment and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.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.

Event Description

It was reported to philips the device failed to deliver a shock.After the user checked connections, the device again did not shock.There was a need to maintain basic and advanced life support until the user could retrieve another device which delayed defibrillation for the patient.The device was reported to be in use on a patient, causing a delay in life threatening therapy/treatment and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.The device as powered on at 5:08:56 pm into the monitor mode and an ¿equipment disabled: therapy¿ message was recorded.Ecg leads were placed and there was a ¿vfib/vtach alarm at 0:06 elapsed time (et) followed by several ¿external paddles on¿ and ¿external paddles off¿ messages over about 30 seconds.No energy was charged or discharged via the external paddles.The users cycled the power and returned to the monitor mode.There were vtach and extreme tachycardia alarms for the next two minutes.At 3:10 et there was a deflection in the ecg waveform consistent with the delivery of energy which changed the rhythm to a bradycardia.A similar deflection on the waveform was shown at 30:09 et.No energy was charged or delivered by the dfm100 device, therefore, the observed deflections may be the result of shock delivery the different model of external defibrillator used by the clinicians.All waveforms stopped at 39:52 et and the device was powered off at 47:34 et.Review of the hardware log by the product support engineer (pse) showed that on (b)(6) 2020 at 4:18:58pm, before the device was put into clinical use, the opcheck failed and resulted in an ¿equipment disabled: therapy¿ message and a red x.The opcheck failed because it was improperly performed.Refer to instruction for use, edition1.7(453564403811), page162."if the efficia dfm100 is not set up correctly, the display prompts you to make the required changes for a successful operational check (see figure 73).The therapy knob must be set to 170j to begin operational check.Once the check begins, set the knob back to 150j when prompted to do so.Operational check runs automatically.If you choose to proceed without setting up properly, the operational check may fail." the device was tested and the philips fse was unable to reproduce the customer's reported problem.The error message occurred because of an improperly performed opcheck.Once the opcheck was performed properly the device passed all testing.There was no malfunction of the device.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: 10645192
• MDR Text Key: 210362781
• Report Number: 1218950-2020-05936
• 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: 09/30/2020

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: 09/30/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening