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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; BREATHING CIRCUIT CIRCULATOR
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; BREATHING CIRCUIT CIRCULATOR Back to Search Results
Lot Number 210729
Device Problem Fitting Problem (2183)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2021
Event Type  malfunction  
Event Description
It was reported that during pre-test, the customer noticed the connection between the breathing circuit and the breathing filter was loose.No patient injury.No additional information is available for this complaint.
 
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Type of Device
BREATHING CIRCUIT CIRCULATOR
MDR Report Key12522925
MDR Text Key273084934
Report Number3012307300-2021-09573
Device Sequence Number1
Product Code CAG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 09/23/2021
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 Lot Number210729
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/24/2021
Initial Date FDA Received09/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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