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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX GENERAL ANESTHESIA CIRCUITS; CAG
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NULL PORTEX GENERAL ANESTHESIA CIRCUITS; CAG Back to Search Results
Catalog Number C45041345-NLJ
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2021
Event Type  malfunction  
Event Description
It was reported that during a pre-use check, the customer noticed the diameter of the swivel connector was larger than normal, which did not allow the product to be connected to a mating component properly.No patient injury.No additional information is available for this complaint.
 
Manufacturer Narrative
Other, other text: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could not be duplicated.The device passed all functional tests.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
CAG
Manufacturer (Section G)
NULL
MDR Report Key13142459
MDR Text Key283100150
Report Number3012307300-2022-00008
Device Sequence Number1
Product Code CAG
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 03/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberC45041345-NLJ
Device Lot Number4147547
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2022
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/06/2021
Initial Date FDA Received01/03/2022
Supplement Dates Manufacturer Received03/20/2022
Supplement Dates FDA Received03/23/2022
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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