MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART XL+ DEFIBRILLATOR/MONITOR

Model Number 861290

Device Problems Failure to Deliver Shock/Stimulation (1133); Unexpected Shutdown (4019)

Patient Problem Loss of consciousness (2418)

Event Date 09/02/2021

Event Type  Injury  

Manufacturer Narrative

Reporting institution phone : (b)(6).

Event Description

It was reported to philips that while a patient was being monitored on defib, the patient went into unconsciousness.Emergency department staff selected 200 joules and were ready to defibrillate when the screen went blank.Staff turned it off and then back on.The device has a reconditioned battery, checked ecg lead set- all okay, checked pads adaptor cable -all okay.Downloaded logs to usb.

Manufacturer Narrative

The customer requested that a philips field service engineer (fse) be dispatched to the customer site.An evaluation was completed and the fse was unable to replicate the alleged failure.Information received from the customer stated that during troubleshooting by staff during the event, it was noted the pads were placed over an ecg dot, with leads tangled underneath the pad.Therefore, had minimal contact with the pad and skin/chest.Once this was rectified and pads put on properly, pads charged and shocked appropriately.The customer also noted during an earlier follow up that the device has a reconditioned battery.The customer also stated that they checked the ecg lead set and the pads adaptor cable and that all were okay.A philips product support engineer reviewed the provided logs and summaries.Per the hardware log evaluation, there were no failures other than opchecks.The software logs confirm that on 09 feb 2022 at 11:17:21 am, the device was in use in clinical mode and encountered a hardware watchdog and therefore, by design, rebooted itself.The reboot was successful and the software log recorded this at 11:17:23, two seconds later.The xl+ is designed to reboot itself when these occur in an attempt to clear the condition.In this case the device successfully rebooted and no other errors are shown in the logs.No ecg monitoring strips or case event files were provided to philips for review.Upon conclusion of the evaluation, the device was found to be fully functional with no replacement parts required.At this point in time, philips is unable to rule out that a malfunction did not occur, however the information received from the customer pointed to user error.As the issue could not be replicated during evaluation, a definitive cause for the alleged failure could not be determined.The hardware logs shows there were no malfunctions, however the software logs showed that the device encountered a hardware watchdog, and therefore by design, rebooted itself.The reboot was successful.No additional errors are shown in the log.The available information from this report does not support that this malfunction represents a systemic, design, or labeling problem.No further investigation or action is warranted.The device passed all required testing and was deemed fit for use.The device remains at the customer site.The available information from this report does not support that this malfunction represents a systemic, design, or labeling problem.No further investigation or action is warranted.

Event Description

It was reported to philips that while a patient was being monitored on the defibrillator, the patient went into unconsciousness.The emergency department staff selected 200 joules and were ready to defibrillate when the screen went blank.The staff turned it off and then back on.

• Brand Name: HEARTSTART XL+ DEFIBRILLATOR/MONITOR
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: kara grubbs ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 13660303
• MDR Text Key: 286510333
• Report Number: 3030677-2022-01360
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838023680
• UDI-Public: 00884838023680
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K110825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/03/2022
• Supplement Dates Manufacturer Received: 04/18/2022
• Supplement Dates FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening