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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA BREATHING HOSE, DISPOSABLE BREATHING HOSE DISPOSABLE

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DRÄGERWERK AG & CO. KGAA BREATHING HOSE, DISPOSABLE BREATHING HOSE DISPOSABLE Back to Search Results
Catalog Number MP02721
Device Problems Detachment of Device or Device Component (2907); Insufficient Information (3190)
Event Date 01/25/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
 
Event Description
It was reported that the y-piece disconnected during use resulting in an interruption of gas delivery to the patient. There was no injury reported.
 
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Brand NameBREATHING HOSE, DISPOSABLE
Type of DeviceBREATHING HOSE DISPOSABLE
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM 23542
MDR Report Key11391704
MDR Text Key246315237
Report Number9611500-2021-00093
Device Sequence Number1
Product Code CAI
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 05/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMP02721
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

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