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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
Model Number C45101340-NLJ
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/19/2021
Event Type  malfunction  
Event Description
It was reported that during the pre-use check, an error from the anesthesia device was observed.The customer suspected leakage of air or occlusion occurred in the product.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 not be duplicated and 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
CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE
Manufacturer (Section G)
NULL
MDR Report Key12975665
MDR Text Key282099526
Report Number3012307300-2021-12592
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
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberC45101340-NLJ
Device Catalogue NumberC45101340-NLJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/24/2022
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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