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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 Mechanics Altered (2984)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2022
Event Type  malfunction  
Event Description
It was reported to philips that the device therapy port connector is mechanically unstable.There was no report of patient involvement.The manufacturer's authorized field service engineer (fse) evaluated the device and confirmed the reported problem.Upon conclusion of the evaluation, it was determined that this was a malfunction of the therapy port connector, which was tightened.The device remains at the customer site and no further evaluation is warranted at this time.
 
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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
jazmin del rosa
22100 bothell everett highway
bothell, WA 98021
9095703538
MDR Report Key14787900
MDR Text Key294865851
Report Number3030677-2022-03163
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838006652
UDI-Public00884838006652
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K031187
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 Received06/23/2022
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
Date Manufacturer Received06/14/2022
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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