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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART MRX -EMS DEFIBRILLATOR
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PHILIPS NORTH AMERICA LLC HEARTSTART MRX -EMS DEFIBRILLATOR Back to Search Results
Model Number M3536A
Device Problem Sparking (2595)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/14/2022
Event Type  malfunction  
Event Description
It was reported to philips that the paddles have a sparking issue.There was no patient involvement.The field service engineer (fse) found that the paddle trays needed to be replaced.Upon conclusion of the evaluation, it was determined that the paddle trays requires replacement.They were replaced.The device passed testing and was put back into service.
 
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Brand Name
HEARTSTART MRX -EMS DEFIBRILLATOR
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 Key13677945
MDR Text Key286655532
Report Number3030677-2022-01404
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838006652
UDI-Public00884838006652
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K031187
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
Date FDA Received03/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM3536A
Device Catalogue NumberM3536A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/24/2015
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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