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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT ENTRANT HF; No Match
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ABBOTT ENTRANT HF; No Match Back to Search Results
Model Number CDHFA300Q
Device Problems Incorrect Measurement (1383); Interrogation Problem (4017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/22/2023
Event Type  malfunction  
Event Description
During an in-clinic follow-up, a diagnostic anomaly occurred when the device was interrogated.Upon interrogating the device again, all electrical measurements were normal.Abbott technical support was contacted and suspected the incorrect measurements were caused by a telemetry anomaly.No intervention was performed at this time.The patient was stable and will continue to be monitored.
 
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Brand Name
ENTRANT 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 Key18455637
MDR Text Key332204885
Report Number2017865-2024-00519
Device Sequence Number1
Product Code NIK
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
Report Date 01/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCDHFA300Q
Device Lot NumberS000090652
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/22/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2023
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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