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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AVANCE CS2; ANESTHESIA GAS MACHINE
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DATEX-OHMEDA, INC. AVANCE CS2; ANESTHESIA GAS MACHINE Back to Search Results
Model Number 1009-9050-000
Device Problem Device Fell (4014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/21/2020
Event Type  malfunction  
Manufacturer Narrative
No report of patient involvement.A ge healthcare service representative performed a checkout of the system, and confirmed the reported issue.The bag arm was replaced to resolve the reported issue.
 
Event Description
The hospital reported the display mount is broken, and the display fell off of the mounting arm.There was no report of patient involvement.
 
Manufacturer Narrative
Additional review of the event determined the event would be noted during pre-use testing as contained in the user manual and was not hazard that could lead to death or serious injury.There was no malfunction and no death or serious injury.The unit will continue to ventilate and alarms remain functional.The initial event was not a reportable malfunction.H3 other text: additional review of the event determined the event would be noted during pre-use testing as contained in the user manual and was not hazard that could lead to death or serious injury.There was no malfunction and no death or serious injury.The unit will continue to ventilate and alarms remain functional.The initial event was not a reportable malfunction.
 
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Brand Name
AVANCE CS2
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
MDR Report Key10696283
MDR Text Key211857038
Report Number2112667-2020-02875
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K172045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 06/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1009-9050-000
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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