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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AVANCE; ANESTHESIA GAS MACHINE

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DATEX-OHMEDA, INC. AVANCE; ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 09/28/2017
Event Type  malfunction  
Manufacturer Narrative
No report of patient involvement.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.The date of manufacture was unavailable at the time of filing.A ge healthcare service representative performed a checkout of the system.The bag/vent switch was replaced to resolve the reported issue.
 
Event Description
During a service visit, ge healthcare service representative noted that the bag/vent switch was not functioning as expected.There was no report of patient involvement.
 
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Brand Name
AVANCE
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison WI 53718
Manufacturer Contact
joseph seliga
3000 n grandview blvd.
waukesha, WI 53188
2625443620
MDR Report Key7219865
MDR Text Key98298159
Report Number2112667-2018-00204
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K032803
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial
Report Date 01/25/2017
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
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/28/2017
Initial Date FDA Received01/25/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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