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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX GENERAL ANESTHESIA CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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NULL PORTEX GENERAL ANESTHESIA CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Catalog Number CA25K0/400/000JP
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2022
Event Type  malfunction  
Event Description
It was reported that the product was unable to pass the pre-use air leak test.No patient involvement.
 
Manufacturer Narrative
The device was returned.After conducting a leak test, it was confirmed that it did not conform to manufacturer standards.The potential root cause may be a manufacturing deficiency or screw and barrel wear.This complaint is confirmed.Manufacturing device history review (dhr) could not be performed because the product lot number was not provided.510(k) is unknown.
 
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Brand Name
PORTEX GENERAL ANESTHESIA CIRCUITS
Type of Device
CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section G)
NULL
MDR Report Key14345998
MDR Text Key291292237
Report Number3012307300-2022-08351
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 09/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCA25K0/400/000JP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2022
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/10/2022
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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