• 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 GSP; 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 GSP; ANESTHESIA UNITS Back to Search Results
Catalog Number 8607000
Device Problems Failure to Deliver (2338); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/27/2023
Event Type  malfunction  
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.
 
Event Description
It was reported that the machine went into ventilator failure.The patient was bagged for the rest of the case.There was no patient injury reported.
 
Manufacturer Narrative
During on-site checking in follow-up to the event, the draeger service technician detected three faulty parts (pressure transducer on a control pcb, the electronical peep valve and the light barrier) and replaced them accordingly.Afterwards, the device was tested and confirmed to be operating per manufacturer¿s specification.The parts as well as the electronic device logfile were requested for investigation at the manufacturer¿s site but were unfortunately not available.Since the device is almost 18 years old, it is likely that the vent fail was caused by wear and tear of (one of) the replaced component(s).However, due to lack of information, a differentiation is not possible.Checking the ventilator operation is part of the daily and pre-use check (described in the instruction for use) and must be carried out before each patient use.Based on the given information, it can be concluded that the ventilator failure was related to the aspect that the supervisor function of the fabius system detected an issue that forced a shut-down of automatic ventilation according to its safety concept.Such a ventilator shutdown is accompanied by the corresponding vent fail alarm.The user can switch to manual ventilation as described in the instructions for use.Monitoring is still functional.
 
Event Description
It was reported that the machine went into ventilator failure.The patient was bagged for the rest of the case.There was no patient injury reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FABIUS GSP
Type of Device
ANESTHESIA 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
Manufacturer Contact
moislinger allee 53-55
lübeck 23542
4518822868
MDR Report Key18805904
MDR Text Key336640434
Report Number9611500-2024-00085
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 04/11/2024
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 Catalogue Number8607000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/02/2024
Initial Date FDA Received02/29/2024
Supplement Dates Manufacturer Received02/02/2024
Supplement Dates FDA Received04/11/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-