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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GALLANT DR; No Match
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ABBOTT GALLANT DR; No Match Back to Search Results
Model Number CDDRA500Q
Device Problems Failure to Interrogate (1332); Environmental Compatibility Problem (2929); Inappropriate or Unexpected Reset (2959)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
During a clinic follow-up, the device was unable to be interrogated.Upon investigation, it was revealed that the device was in backup vvi (bvvi) mode.The cause of the bvvi was found to be off-label mri exposure.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
GALLANT DR
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 Key18812021
MDR Text Key336615198
Report Number2017865-2024-33807
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeFR
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 02/29/2024
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 Expiration Date11/30/2023
Device Model NumberCDDRA500Q
Device Lot NumberP000135108
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/14/2024
Initial Date FDA Received02/29/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/07/2021
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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