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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 01/11/2022
Event Type  malfunction  
Event Description
It was reported to philips that the external paddles are not working.There was no patient involvement.The field service engineer (fse) confirmed the external paddles were not working.Upon conclusion of the evaluation, it was determined that this was a malfunction of the external paddles ((b)(4)), the replacement for which to be ordered by customer.The customer to install paddles.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
daniel derochers
22100 bothell everett highway
bothell, WA 98021
9095703538
MDR Report Key13419578
MDR Text Key284859094
Report Number3030677-2022-00625
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838023680
UDI-Public00884838023680
Combination Product (y/n)N
Reporter Country CodeIN
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/11/2022
Initial Date FDA Received02/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2012
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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