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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 Problems Inadequate User Interface (2958); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/07/2021
Event Type  malfunction  
Event Description
It was reported to philips that the device had damaged buttons.There was no patient involvement.
 
Event Description
It was reported to philips that the device had damaged buttons.The customer requested that a philips field service engineer (fse) be dispatched to the customer site.Upon evaluation of the device, the reported issue was confirmed, and the cause was traced to a damaged display cover.Based on the conclusion of the evaluation, it was determined that this was a malfunction of the display cover.The display cover was replaced and the device passed all performance assurance testing.The device remains at the customer site.There is no indication of a systemic problem.No further investigation or action is warranted.
 
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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 Key12100059
MDR Text Key259396526
Report Number3030677-2021-12627
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
Date FDA Received07/01/2021
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
Distributor Facility Aware Date06/07/2021
Date Manufacturer Received06/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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