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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA VENTSTAR® COAXIAL WATER TRAP 210; BREATHING CIRCUITS DISPOSABLE
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DRÄGERWERK AG & CO. KGAA VENTSTAR® COAXIAL WATER TRAP 210; BREATHING CIRCUITS DISPOSABLE Back to Search Results
Catalog Number MP00373
Device Problems Obstruction of Flow (2423); Detachment of Device or Device Component (2907); Gas/Air Leak (2946)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2022
Event Type  malfunction  
Event Description
It was reported that the inner lumen of the circuit has come apart.Patient was under active resuscitation when it was detected that the inner lumen has come apart from the connector at the patient end.The connector feels loose and the outer lumen swivelled reasonably freely.
 
Manufacturer Narrative
The investigation was just started.The result will be forwarded in a follow-up report.
 
Event Description
It was reported that the inner lumen of the circuit has come apart.Patient was under active resuscitation when it was detected that the inner lumen has come apart from the connector at the patient end.The connector feels loose and the outer lumen swivelled reasonably freely.
 
Manufacturer Narrative
The affected hose system of type ventstar coax was available for investigation.During the analysis at manufacturing site the described issue could be confirmed.The inner coax circuit was disconnected from the y-piece.This results in co2 rebreathing.The increased co2 is detected by the connected main device and depending on the set alarm limits a corresponding alarm will be posted.Our investigations have shown that the adhesive joint did not conform to specification due to an unstable manufacturing process.A capa was opened to initiate and document further measures.In april 2023, dräger has already informed all customers of potentially affected products about the identified risk with a field safety notice.
 
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Brand Name
VENTSTAR® COAXIAL WATER TRAP 210
Type of Device
BREATHING CIRCUITS DISPOSABLE
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck
GM 
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM   23542
Manufacturer Contact
moislinger allee 53-55
lübeck 23542
4518822868
MDR Report Key16110861
MDR Text Key306916455
Report Number9611500-2023-00005
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 User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberMP00373
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/02/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
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