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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX GENERAL ANESTHESIA CIRCUITS; BREATHING-CIRCUIT
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NULL PORTEX GENERAL ANESTHESIA CIRCUITS; BREATHING-CIRCUIT Back to Search Results
Model Number CA1700/000/000JP
Device Problem Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 10/01/2021
Event Type  malfunction  
Event Description
It was reported that during the pre-use check, leakage of air from the breathing circuit was observed.No patient injury.
 
Manufacturer Narrative
Other, other text: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.Leakage is confirmed due to a hole through the circuit, but the problem source could not be identified.Dhr review was done, no issues related to the original complaint were found.
 
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Brand Name
PORTEX GENERAL ANESTHESIA CIRCUITS
Type of Device
BREATHING-CIRCUIT
Manufacturer (Section G)
NULL
MDR Report Key12749118
MDR Text Key280008892
Report Number3012307300-2021-10680
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,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCA1700/000/000JP
Device Catalogue NumberCA1700/000/000JP
Device Lot Number210902
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/31/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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