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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
Lot Number 210608
Device Problem Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2021
Event Type  malfunction  
Event Description
It was reported that during the pre-use check, leakage of air from the product was detected.No patient injury was reported.
 
Manufacturer Narrative
The breathing circuit and the hme filter were returned.Defective component (breathing circuit).Item number: c37101307j.Lot number: 4077822.Observation of the returned breathing circuit and the hme filter revealed no abnormalities such as damage related to the reported event.Next, we conducted a leak test on the breathing circuit and the hme filter, but no leaks were confirmed, and it was confirmed that the product conformed to the standard.Conclusion: the reported event was not confirmed.Root cause: the root cause was not identified dhr review was completed.
 
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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 Key13428258
MDR Text Key287196422
Report Number3012307300-2022-02389
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,Health Professional
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 Date09/11/2023
Device Lot Number210608
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2021
Was the Report Sent to FDA? No
Date Manufacturer Received07/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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