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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 Energy Output Problem (1431); Failure of Device to Self-Test (2937)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/10/2021
Event Type  malfunction  
Event Description
While performing preventative maintenance on the device, the customer noted the device had experienced a defib failure during operational testing.Additionally, the capacitor output was not within product specifications.There was no patient involvement.
 
Event Description
While performing preventative maintenance on the device, the customer noted the device had experienced a defib failure during operational testing.Additionally, the capacitor output was not within product specifications.There was no patient involvement.
 
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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 Key11425142
MDR Text Key238609403
Report Number3030677-2021-10110
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
Distributor Facility Aware Date02/10/2021
Initial Date Manufacturer Received 02/10/2021
Initial Date FDA Received03/05/2021
Supplement Dates Manufacturer Received02/10/2021
Supplement Dates FDA Received05/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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