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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA VENTSTAR ANAESTHESIA WF 280; BREATHING HOSE , DISPOSABLE
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DRÄGERWERK AG & CO. KGAA VENTSTAR ANAESTHESIA WF 280; BREATHING HOSE , DISPOSABLE Back to Search Results
Device Problems Fracture (1260); Gas/Air Leak (2946)
Patient Problem Low Oxygen Saturation (2477)
Event Date 02/27/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation is still on-going.The results will be provided within a follow-up report.
 
Event Description
It was reported that the tubes that are connected to the y-piece disconnect easily and cause a break in delivery of oxygen and anesthesia gases.In this case the tubes disconnected during a carotid endarterectomy leading to the patient desaturating whilst the clinician tried to locate the origin of the leak.
 
Manufacturer Narrative
A ventstar anesthesia wf 280 tubing system was available for investigation.The reported error pattern could be comprehended during the optical inspection- one of the patient side connectors was found to be disconnected from the hose.Upon closer examination of the loose connector, residual adhesive was visible on the connector and on the tube.In principle, the failure (broken bond) can be caused by a too small amount of adhesive, whereby the exact amount of the adhesive used cannot be identified.Incorrect handling, in which the connectors are touched and turned on the bond and not on the corrugation, is also a conceivable root cause of the error pattern found.If a loose connection leads to a leakage that cannot be compensated by the connected main unit, this is detected during the pre-use test or during ventilation and is alerted accordingly.The number of similar cases, related to the same symptom, is within the expected range of the respective risk assessment and thus accepted.
 
Event Description
It was reported that the tubes that are connected to the y-piece disconnect easily and cause a break in delivery of oxygen and anesthesia gases.In this case the tubes disconnected during a carotid endarterectomy leading to the patient desaturating whilst the clinician tried to locate the origin of the leak.
 
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Brand Name
VENTSTAR ANAESTHESIA WF 280
Type of Device
BREATHING HOSE , DISPOSABLE
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM  23542
MDR Report Key9985042
MDR Text Key191577662
Report Number9611500-2020-00129
Device Sequence Number1
Product Code OFP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Event Location Hospital
Date Manufacturer Received05/19/2020
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
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