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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE); PORTEX GENERAL ANESTHESIA CIRCUITS
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NULL CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE); PORTEX GENERAL ANESTHESIA CIRCUITS Back to Search Results
Model Number CA1300/0K1/000JP
Device Problem Improper Flow or Infusion (2954)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2021
Event Type  malfunction  
Event Description
It was reported that during pre-test, leakage of air from the product was observed.No patient injury.No additional information is available for this complaint.
 
Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms # (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.Observation of the returned breathing circuit revealed no abnormalities such as damage related to the reported event.A leak test was conducted on the breathing circuit, but no leaks were confirmed, the root cause was not identified.No actions were necessary.
 
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Brand Name
CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Type of Device
PORTEX GENERAL ANESTHESIA CIRCUITS
Manufacturer (Section G)
NULL
MDR Report Key12380046
MDR Text Key270140783
Report Number3012307300-2021-08920
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCA1300/0K1/000JP
Device Catalogue NumberCA1300/0K1/000JP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/19/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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