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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL; BREATHING CIRCUIT CIRCULATOR
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NULL; BREATHING CIRCUIT CIRCULATOR Back to Search Results
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2021
Event Type  malfunction  
Event Description
It was reported that the top dial is not staying locked in the auto setting and moves back to manual.
 
Manufacturer Narrative
H6: event problem and evaluation codes: updated after device evaluation.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection found the momentary valve didn't lock into position.The customer stated problem was duplicated.Replaced momentary valve assy.The cause of the reported problem was traced to the user manipulation of the device.
 
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Type of Device
BREATHING CIRCUIT CIRCULATOR
Manufacturer (Section G)
NULL
MDR Report Key12379037
MDR Text Key268521386
Report Number3012307300-2021-08910
Device Sequence Number1
Product Code CAG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/11/2022
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/02/2021
Initial Date FDA Received08/27/2021
Supplement Dates Manufacturer Received09/03/2021
Supplement Dates FDA Received03/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/10/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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