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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART MRX MONITOR/DEFIB; DEFIBRILLATOR
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PHILIPS NORTH AMERICA LLC HEARTSTART MRX MONITOR/DEFIB; DEFIBRILLATOR Back to Search Results
Model Number M3535A
Device Problem Sparking (2595)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2022
Event Type  malfunction  
Event Description
It was reported to philips that the device had addle damage due to sparking.There was reportedly no patient involvement.The customer worked with the technical support representative.The device is at end of support and no service support is available.The manufacturer is unable to repair the faulty defibrillator.The mrx / m3535a end-of- support date for the device is 3rd february 2022.The customer was aware of the end-of-life terms and the device remains at the customer site.
 
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Brand Name
HEARTSTART MRX MONITOR/DEFIB
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
habba fe dano
22100 bothell everett highway
bothell, WA 98021
9095703538
MDR Report Key13691536
MDR Text Key286756344
Report Number3030677-2022-01421
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838000018
UDI-Public00884838000018
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type 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 Received03/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM3535A
Device Catalogue NumberM3535A
Was Device Available for Evaluation? No
Date Manufacturer Received02/15/2022
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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