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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PORTEX; ANESTHESIA CONDUCTION KIT
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PORTEX; ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number NCE6578JP
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2021
Event Type  malfunction  
Manufacturer Narrative
Returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Problem source was traced to device design.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
Event Description
It was reported that the next day the operation was conducted during the use of the smiths medical product, the customer found leakage of medical fluid from the product.So he checked the epifuse connector and it was found broken in two.No patient injury.
 
Manufacturer Narrative
Other, other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Problem source was traced to device design.The device history record was not reviewed as no lot/serial number was provided.
 
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Brand Name
PORTEX
Type of Device
ANESTHESIA CONDUCTION KIT
MDR Report Key11742987
MDR Text Key247901192
Report Number3012307300-2021-03560
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 05/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberNCE6578JP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2021
Was the Report Sent to FDA? No
Date Manufacturer Received04/21/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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