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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT QUADRA ASSURA MP ICD; No Match
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ABBOTT QUADRA ASSURA MP ICD; No Match Back to Search Results
Model Number CD3371-40QC
Device Problem Incorrect Measurement (1383)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/04/2023
Event Type  malfunction  
Event Description
Following a magnetic resonance imaging (mri), the device was displaying incorrect measurements due to rapid interrogations.As the device records new diagnostic measurements the values were as expected.The patient was stable with no consequences.
 
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Brand Name
QUADRA ASSURA MP ICD
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 Key18380507
MDR Text Key331204455
Report Number2017865-2023-95247
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeUK
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 Health Care Professional
Type of Report Initial
Report Date 12/21/2023
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 Date04/30/2019
Device Model NumberCD3371-40QC
Device Lot NumberA000038772
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/05/2023
Initial Date FDA Received12/21/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/12/2017
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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