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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 Failure to Discharge (1169)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2022
Event Type  malfunction  
Manufacturer Narrative
Reporter phone: (b)(6).
 
Event Description
It was reported that the device shock function failed.There was reportedly no patient involvement.The customer requested to return the device to the bench for evaluation and repair.
 
Manufacturer Narrative
The bench tech evaluated the device and determined that the defibrillator capacitor requires replacement.Upon conclusion of the evaluation, it was determined that this was a malfunction of the defibrillator capacitor, which was replaced, and the device was returned to full functionality.The device returned to the customer site and no further evaluation is warranted at this time.
 
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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
daniel derochers
22100 bothell everett highway
bothell, WA 98021
9095703538
MDR Report Key13636679
MDR Text Key286368290
Report Number3030677-2022-01290
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838000018
UDI-Public00884838000018
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K031187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
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 NumberM3535A
Device Catalogue NumberM3535A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2022
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/16/2022
Initial Date FDA Received03/01/2022
Supplement Dates Manufacturer Received02/16/2022
Supplement Dates FDA Received03/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/26/2011
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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