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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 Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/03/2021
Event Type  malfunction  
Event Description
It was reported to philips the device showed an ecg bias error.There was no patient involvement.
 
Event Description
It was reported to philips the device showed an ecg bias error.There was no patient involvement.A philips field service engineer (fse) evaluated the device.The reported issue was confirmed and traced to a faulty processor pca.The fse replaced the processor pca.The device passed all performance assurance tests and was placed back into use with the customer.
 
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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
MDR Report Key12537553
MDR Text Key273550330
Report Number3030677-2021-14523
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838006652
UDI-Public00884838006652
Combination Product (y/n)N
PMA/PMN Number
K031187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
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 NumberM3536A
Device Catalogue NumberM3536A
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 09/03/2021
Initial Date FDA Received09/27/2021
Supplement Dates Manufacturer Received09/14/2021
Supplement Dates FDA Received10/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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