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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS GS PREMIUM; ANESTHESIA UNIT

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DRÄGERWERK AG & CO. KGAA FABIUS GS PREMIUM; ANESTHESIA UNIT Back to Search Results
Model Number 8607000
Device Problem Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/19/2023
Event Type  malfunction  
Manufacturer Narrative
The user facility did not involve the local dräger s&s organization into examination of the device and potential repair measures.The only further detail that could be obtained is that the device is back in use after exchange of the ventilator motor.A case-specific evaluation is not possible for dräger due to lack of information.There was no s/n transmitted; age of the device and status of repairs and preventive maintenance are unknown to dräger.It is plausible that a sudden occurring issue with the ventilator unit would lead to shut-down of automatic ventilation, the exact mechanism of fault can however not be determined.It cannot be excluded that lack of preventive maintenance has led to the reported event.A shut down of ventilation is accompanied by a corresponding alarm to alert the user.Manual ventilation with the built-in breathing bag remains possible then.H3 other text : device not available for evaluation.
 
Event Description
It was reported that a ventilator failure occurred during use.As per report, the device posted a corresponding alarm.There was no detail in the report which may reasonably suggest that patient consequences were resulting from the event.
 
Manufacturer Narrative
This is a correction of the previous report.The model no.Was corrected.The serial number of the affected fabius gs premium was requested but not provided by the customer.Therefore, the unique device identifier (udi) cannot be determined.
 
Event Description
It was reported that a ventilator failure occurred during use.As per report, the device posted a corresponding alarm.There was no detail in the report which may reasonably suggest that patient consequences were resulting from the event.
 
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Brand Name
FABIUS GS PREMIUM
Type of Device
ANESTHESIA UNIT
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 Key18345447
MDR Text Key330805646
Report Number9611500-2023-00483
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K011404
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8607000
Device Catalogue Number8607000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/21/2023
Initial Date FDA Received12/18/2023
Supplement Dates Manufacturer Received06/06/2024
Supplement Dates FDA Received07/29/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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