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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS MRI ANESTHESIA UNITS

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DRÄGERWERK AG & CO. KGAA FABIUS MRI ANESTHESIA UNITS Back to Search Results
Model Number 8607300
Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Electrical Overstress (2924)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2022
Event Type  malfunction  
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
 
Event Description
It was reported that the ventilator stopped during use of the device. It was mentioned that no consequences to the patient have resulted from that; patient support was done in maunal ventilation.
 
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Brand NameFABIUS MRI
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 Key15291348
MDR Text Key304011145
Report Number9611500-2022-00218
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K072884
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 10/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8607300
Device Catalogue Number8607300
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received10/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/31/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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