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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAEGERWERK AG & CO. KGAA DRAGER OXYLOG 3000 VENTILATOR, CONTINUOUS, FACILITY USE

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DRAEGERWERK AG & CO. KGAA DRAGER OXYLOG 3000 VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number DRAGER OXYLOG 3000
Device Problems Break (1069); Noise, Audible (3273)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2021
Event Type  Malfunction  
Event Description

Ventilator started to make noises on the side of the bed. Author went to look at the ventilator and there was an error message saying "device failure". Fda safety report id# (b)(4).

 
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Brand NameDRAGER OXYLOG 3000
Type of DeviceVENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
DRAEGERWERK AG & CO. KGAA
MDR Report Key11529456
MDR Text Key241488896
Report NumberMW5100124
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 03/17/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/18/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberDRAGER OXYLOG 3000
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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