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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT NEUTRINO NXT HF; NO MATCH
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ABBOTT NEUTRINO NXT HF; NO MATCH Back to Search Results
Model Number CDHFA600Q
Device Problems Environmental Compatibility Problem (2929); Inappropriate or Unexpected Reset (2959)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/02/2023
Event Type  malfunction  
Event Description
It was reported that the device was in backup mode.Further information was requested.
 
Event Description
Additional information was received indicating that the patient was stable.
 
Event Description
Additional information was received indicating the backup mode occurred due to mri where mri settings were not programmed.
 
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Brand Name
NEUTRINO NXT HF
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 Key17965144
MDR Text Key326045428
Report Number2017865-2023-50179
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeSP
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 Other
Type of Report Initial,Followup,Followup
Report Date 12/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCDHFA600Q
Device Lot NumberP000153746
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/11/2022
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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