Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA BREATHING HOSE, DISPOSABLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DRÄGERWERK AG & CO. KGAA BREATHING HOSE, DISPOSABLE Back to Search Results
Device Problem No Pressure (2994)
Patient Problem No Consequences Or Impact To Patient (2199)
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 during anesthesia, circuits became detached from the blue connectors and the y-piece.There was no patient injury reported.
 
Manufacturer Narrative
The affected breathing circuits were requested but were not available for investigation as they had already been disposed by the hospital.Therefore, a root cause analysis was not possible.A loose connection is obvious during preparation for use.Since all connections must be checked for fixed fit and tightness according to the instructions for use, a possibly too loose connection is reliably detected in this frame.A potentially loose angle connector can be firmly connected to the y-piece by re-inserting it.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.Although it was not possible to determine the root cause of the present case, there are cases with a comparable error pattern, the number of which, however, is within the expected range of the respective risk assessment and thus accepted.
 
Event Description
Please refer to the initial-report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BREATHING HOSE, DISPOSABLE
Type of Device
BREATHING HOSE, DISPOSABLE
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck
GM 
MDR Report Key9400249
MDR Text Key177409504
Report Number9611500-2019-00404
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 user facility
Type of Report Initial,Followup
Report Date 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received12/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-