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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX ADULT DISPOSABLE ANESTHESIA BREATHING CIRCU; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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NULL PORTEX ADULT DISPOSABLE ANESTHESIA BREATHING CIRCU; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Device Problem Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/02/2021
Event Type  malfunction  
Event Description
It was reported that during the pre-use check, leakage of air from the breathing circuit was detected.No patient injury was reported.
 
Manufacturer Narrative
Defective component (breathing circuit), item number :c45101314j, lot number :4104011.Observation of the returned breathing circuit and breathing bag revealed no abnormalities such as damage related to the reported event.Next, we conducted a leak test on the breathing circuit and air leakage was confirmed.No leaks were found in the breathing bag and it conformed to the standard.The reported event was confirmed.Root cause: the root cause may be due to manufacturing.Dhr: review of manufacturing records, relevant to the lot reported, found no discrepancies or anomalies.
 
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Brand Name
PORTEX ADULT DISPOSABLE ANESTHESIA BREATHING CIRCU
Type of Device
CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section G)
NULL
MDR Report Key13429039
MDR Text Key286589764
Report Number3012307300-2022-02394
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 Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/15/2024
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2021
Was the Report Sent to FDA? No
Date Manufacturer Received07/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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