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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WESTMED WESTMED FLEX EXTENDER ETT 6.5; TUBING WITH CONNECTORS
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WESTMED WESTMED FLEX EXTENDER ETT 6.5; TUBING WITH CONNECTORS Back to Search Results
Model Number S6420P
Device Problems Break (1069); Occlusion Within Device (1423); Increase in Pressure (1491)
Patient Problem Low Oxygen Saturation (2477)
Event Date 01/27/2017
Event Type  Injury  
Event Description
Pt was undergoing microlaryngoscopy.Pt noted to have high peak and plateau pressure.Confirmed the pt was not experiencing bronchospasm, mainstem intubation, or mucus plugging.Pt maintained slightly low sat, low 90's, with one incident drifting down to a low of 87 over the course of a half an hour.Eventually, examined westmed flex extender (gooseneck), inner diameter noted to be broken into several small pieces, occluding the gooseneck and obstructing ventilation.Gooseneck immediately disconnected and removed.Pt then ventilated without issue.All pieces of plastic were found collected and independently identified by multiple personnel in the room, confirming that no plastic had been introduced into the pt's airway.Bronchoscopy also done confirming no foreign body in airway.
 
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Brand Name
WESTMED FLEX EXTENDER ETT 6.5
Type of Device
TUBING WITH CONNECTORS
Manufacturer (Section D)
WESTMED
tucson AZ
MDR Report Key6380426
MDR Text Key69252707
Report NumberMW5068265
Device Sequence Number1
Product Code BYX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberS6420P
Device Lot Number110816T04
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/03/2017
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age55 YR
Patient Weight81
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