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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.
 
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Brand NameHEARTSTART XL+ DEFIBRILLATOR/MONITOR
Type of DeviceDEFIBRILLATOR
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
bethany glynn
22100 bothell everett highway
bothell, WA 98021
9095703538
MDR Report Key11890069
MDR Text Key252808870
Report Number3030677-2021-11765
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K110825
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other Health Care Professional
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
Device Model Number861290
Device Catalogue Number861290
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date05/25/2021
Event Location No Information
Date Manufacturer Received08/25/2021
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 Treatment Data
Date Received: 05/26/2021 Patient Sequence Number: 1
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