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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT NEUTRINO NXT VR; NO MATCH

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ABBOTT NEUTRINO NXT VR; NO MATCH Back to Search Results
Model Number CDVRA600Q
Device Problems Environmental Compatibility Problem (2929); Inappropriate or Unexpected Reset (2959)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/03/2024
Event Type  malfunction  
Event Description
Following an mri procedure the device was observed to be in backup mode.Abbott technical support was contacted and the device was reprogrammed to resolve the event.The patient was in stable condition.
 
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Brand Name
NEUTRINO NXT VR
Type of Device
NO MATCH
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer Contact
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key19143892
MDR Text Key340604568
Report Number2017865-2024-39131
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05415067034373
UDI-Public(01)05415067034373(10)P000170351(17)250531
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/24/2024
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 NumberCDVRA600Q
Device Lot NumberP000170351
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/19/2024
Supplement Dates Manufacturer Received04/24/2024
Supplement Dates FDA Received04/24/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/17/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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