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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 Problem Failure to Discharge (1169)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/21/2024
Event Type  malfunction  
Event Description
Philips received a complaint on the heartstart xl+ defibrillator indicating that the device had an inability to discharge.There was no patient involvement.The fse evaluated the device on site and confirmed the reported problem.The fse performed a restart of the device which resolved the reported issue.The device remains at the customer site and no further evaluation is warranted at this time.
 
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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
Manufacturer (Section G)
PHILIPS NORTH AMERICA LLC
22100 bothell everett highway
bothell WA 98021
Manufacturer Contact
tanya deschmidt
22100 bothell everett highway
bothell, WA 98021
9095703538
MDR Report Key18988079
MDR Text Key338728071
Report Number3030677-2024-01147
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838023680
UDI-Public00884838023680
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K110825
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number861290
Device Catalogue Number861290
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/21/2024
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 Number1
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