• 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 FABIUS GS ANESTHESIA UNITS

  • 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 FABIUS GS ANESTHESIA UNITS Back to Search Results
Device Problems Failure to Deliver (2338); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/29/2021
Event Type  malfunction  
Manufacturer Narrative
The device is not under a service contract, the event was reported with 6 weeks delay and, dräger was not able to obtain any further information from the user facility. It is not known if the device is back in use and if so if any parts have been replaced to put back the workstation into operable state. Hence, there¿s only a general assessment possible. Under consideration that a ventilator failure has occurred the device will post a corresponding alarm to alert the user. Manual ventilation with the built-in breathing back would be possible. Root causes for a ventilator failure may be multiple; the device was in operation for 12 years now and, service state is unknown. A reliable conclusion is not possible due to lack of information. In fact, even the aspect of a ventilator failure cannot be confirmed for the particular case ¿ a large leakage in the patient hose system may also be perceived by users as a ventilator failure when no flow is recognized at the patient opening.
 
Event Description
It was reported that a ventilator failure occurred during use of the device. There was no detail in the report which would reasonably suggest that any patient consequences may have occurred.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFABIUS GS
Type of DeviceANESTHESIA UNITS
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 Key13025239
MDR Text Key284304149
Report Number9611500-2021-00512
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,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-