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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PORTEX; TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION
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PORTEX; TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION Back to Search Results
Model Number 198-32L
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/25/2021
Event Type  malfunction  
Event Description
The customer confirmed in a pre-use check that the product worked properly.However, air was leaking from the cuff during the use of the product, which did not allow him to use it properly.No patient injury.
 
Manufacturer Narrative
Other, other text: one photo was returned for analysis.No defects could be seen in the photograph.The complaint was not confirmed.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.
 
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Brand Name
PORTEX
Type of Device
TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION
MDR Report Key11383221
MDR Text Key233727181
Report Number3012307300-2021-01584
Device Sequence Number1
Product Code CBI
UDI-Device Identifier15019315058608
UDI-Public15019315058608
Combination Product (y/n)N
PMA/PMN Number
K953483
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 06/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date03/18/2023
Device Model Number198-32L
Device Catalogue Number198-32L
Device Lot Number3955980
Was Device Available for Evaluation? No
Date Returned to Manufacturer01/27/2021
Was the Report Sent to FDA? No
Date Manufacturer Received05/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/12/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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