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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART XL+ DEFIBRILLATOR/MONITOR
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PHILIPS NORTH AMERICA LLC HEARTSTART XL+ DEFIBRILLATOR/MONITOR Back to Search Results
Model Number 861290
Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Unintended Electrical Shock (4018)
Patient Problems Bradycardia (1751); Cardiac Arrest (1762)
Event Date 05/21/2021
Event Type  Injury  
Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
 
Event Description
It was reported to philips that the heartstart xl+ was connected to hospital monitoring with ecg for a patient during cardiac arrest.The user connected philips defibrillation pads on the patient and to the heartstart xl+.The user did not see ecg on the xl+ display.The defib-pads were disconnected from the defib-cable and then connected again; there was still no ecg on the xl+.One of the staff was pressing the charge button and took one step back from the defibrillator.Suddenly a shock occurred during cpr.One of the staff got current in his/hers hands.The doctor noted sinus waveform on the monitoring system.Additional details have been requested.The device was reported to be in use on a patient, causing a delay in life saving therapy and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.
 
Manufacturer Narrative
Reporting institution phone: (b)(6).Reporter phone: (b)(6).
 
Event Description
It was reported to philips that the heartstart xl+ was connected to hospital monitoring with ecg for a patient during cardiac arrest.The user connected philips defibrillation pads on the patient and to the heartstart xl+.The user did not see ecg on the xl+ display.The defib-pads were disconnected from the defib-cable and then connected again; there was still no ecg on the xl+.One of the staff was pressing the charge button and took one step back from the defibrillator.Suddenly a shock occurred during cpr.One of the staff got current in his/hers hands.The doctor noted sinus waveform on the monitoring system.Additional details have been requested.The device was reported to be in use on a patient, causing a delay in life saving therapy and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.The involved staff do not think that the device behavior impacted the patient outcome.The patient has normal sinus waveform on the monitoring system after the defibrillation.The staff agree that there are uncertainty whether it was correct decision to defibrillate.A philips clinician reviewed the provided patient event file.It was found that there was no viewable ecg waveform in the patient event file which was consistent with the customer report that no ecg waveform was present on the xl+ display.The event log showed that the device was powered on in manual mode at the 150j energy setting.A ¿pads marginal¿ and a ¿pads off¿ message were observed prior to a ¿pads on¿ message.This is consistent with the customer report that the pads were disconnected from the therapy cable and reconnected in an attempt to resolve the issue of no ecg waveform on the device display.The xl+ was charged to 150j at 00:36 seconds elapsed time and the shock was delivered at 00:41 seconds.Just over one minute after the shock was delivered, ¿pads marginal¿, ¿pads off¿, and ¿pads on¿ messages were again observed within seconds of each other.The device was powered off approximately four minutes later.No further information was available.A philips authorized service provider (asp) evaluated the device and was unable to duplicate the issue.No parts were replaced.The device passed all performance assurance tests and was placed back into use with the customer.Based on the device file provided for review, it was not possible to determine how the defibrillation shock was initiated.There was no long lag time or delay in shock delivery from the time the device was charged.The shock was delivered five seconds after being charged.
 
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Brand Name
HEARTSTART XL+ DEFIBRILLATOR/MONITOR
Type of Device
DEFIBRILLATOR
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
22100 bothell everett highway
bothell WA 98021
MDR Report Key11890069
MDR Text Key252808870
Report Number3030677-2021-11765
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838023680
UDI-Public00884838023680
Combination Product (y/n)N
PMA/PMN Number
K110825
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number861290
Device Catalogue Number861290
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date05/25/2021
Date Manufacturer Received08/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age30 YR
Patient Weight135
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