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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA VENTSTAR COAX (P) 150; BREATHING HOSE DISPOSABLE
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DRÄGERWERK AG & CO. KGAA VENTSTAR COAX (P) 150; BREATHING HOSE DISPOSABLE Back to Search Results
Catalog Number MP00379
Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Misassembly by Users (3133)
Patient Problems Aspiration/Inhalation (1725); Hypoxia (1918); Foreign Body In Patient (2687)
Event Date 06/23/2021
Event Type  Injury  
Manufacturer Narrative
The investigation is still on-going.The results will be provided with a follow-up report.
 
Event Description
It was reported that during anesthesia after an emergency admission of an infant (10 months) with foreign body aspiration, the ventstar coax (p) 150 disconnected from the perseus anesthesia machine.The short connecting tube between the t-piece on the device side and the device connection for inspiration was then plugged directly into the expiration connection.As a result, the ventilation tube on the patient side was no longer connected to the device.The child could therefore no longer be ventilated.Due to the diagnosis of "foreign body aspiration", the medical staff assumed that the patient's airway was now completely closed and therefore did not interpret the alarms of the device correctly.As a result, the child was not ventilated for a long time and therefore had to be flown to a university hospital in critical condition.The patient's life is now out of danger, but permanent damage due to the lack of oxygen can only be assessed with further development.According to the customer's statement, no fault could be found in the tube system.
 
Manufacturer Narrative
The affected ventstar coax disposable coaxial breathing circuit was available for investigation.As reported, the hose system had become detached from the anesthesia machine during use, as well as the connection between the flex and coax hose, which is a plug-in connection.Visual inspection of the tubing system did not reveal any deviations from the specification.The instructions for use describe that all connections must be checked for tight fit and leakage before use.As a result of the deconnection of the hose system, a faulty connection of the hose system occurred, as also confirmed by the user.Thereby, the flex hose was connected to both the inspiration and expiration ports of the device and the coax hose was connected to the y-piece, so that the patient was not connected to the device and could not be ventilated.The instructions for use of the breathing circuit describe the arrangement of the tubing, t-piece and y-piece schematically.The perseus has an integrated gas measurement system which measures the o2, co2 and anesthetic gas concentration at the y-piece.In the event of an error, the o2 value drops while the co2 value rises.This results in visual and audible alarms (insp.O2 low, insp.Co2 high).In addition, perseus monitors the co2 concentration over time.Since no respiratory phase is detected in such a case, the device generates an apnoe co2 alarm.Furthermore, there is also an increase in the airway pressure, which is alerted accordingly by the device when the set alarm limits are reached.No evidence of product or device failure was found during the investigation.It is likely that the user did not adequately attach the tubing or check the connection.The number of similar cases, related to the same root cause (user error), is within the expected range of the respective risk assessment and thus accepted.
 
Event Description
It was reported that during anesthesia after an emergency admission of an infant (10 months) with foreign body aspiration, the ventstar coax (p) 150 disconnected from the perseus anesthesia machine.The short connecting tube between the t-piece on the device side and the device connection for inspiration was then plugged directly into the expiration connection.As a result, the ventilation tube on the patient side was no longer connected to the device.The child could therefore no longer be ventilated.Due to the diagnosis of "foreign body aspiration", the medical staff assumed that the patient's airway was now completely closed and therefore did not interpret the alarms of the device correctly.As a result, the child was not ventilated for a long time and therefore had to be flown to a (b)(6) hospital in critical condition.The patient's life is now out of danger, but permanent damage due to the lack of oxygen can only be assessed with further development.According to the customer's statement, no fault could be found in the tube system.
 
Manufacturer Narrative
Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.
 
Event Description
It was reported that during anesthesia after an emergency admission of an infant (10 months) with foreign body aspiration, the ventstar coax (p) 150 disconnected from the perseus anesthesia machine.The short connecting tube between the t-piece on the device side and the device connection for inspiration was then plugged directly into the expiration connection.As a result, the ventilation tube on the patient side was no longer connected to the device.The child could therefore no longer be ventilated.Due to the diagnosis of "foreign body aspiration", the medical staff assumed that the patient's airway was now completely closed and therefore did not interpret the alarms of the device correctly.As a result, the child was not ventilated for a long time and therefore had to be flown to a university hospital in critical condition.The patient's life is now out of danger, but permanent damage due to the lack of oxygen can only be assessed with further development.According to the customer's statement, no fault could be found in the tube system.
 
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Brand Name
VENTSTAR COAX (P) 150
Type of Device
BREATHING HOSE 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
MDR Report Key12133805
MDR Text Key260426836
Report Number9611500-2021-00296
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,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 05/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberMP00379
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/06/2021
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 Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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