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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 Output below Specifications (3004)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/22/2021
Event Type  malfunction  
Event Description
While performing bench service for the device, it was identified by an authorized bench technician that the output for the capacitor was measuring below product specifications.There was no patient involvement.
 
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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
jacqueline nishino
22100 bothell everett highway
bothell, WA 98021
9095703538
MDR Report Key12334220
MDR Text Key267002175
Report Number3030677-2021-13674
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 Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2021
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date07/22/2021
Date Manufacturer Received07/22/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/25/2008
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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