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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 Sticking (1597)
Patient Problem No Patient Involvement (2645)
Event Date 05/28/2018
Event Type  malfunction  
Manufacturer Narrative
A gehc service representative performed a checkout of the equipment and confirmed the reported complaint. The microswitch was cleaned and adjusted. 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. Date of device manufacture year is 2004. The month of manufacture was unavailable at time of mdr filing.
 
Event Description
The hospital reported the bag/vent switch was sticking. There was no report of patient involvement.
 
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Brand NameAVANCE
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key7631026
MDR Text Key112158294
Report Number2112667-2018-01273
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 06/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/1970
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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