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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. EXCEL 80 ANESTHESIA MACHINE

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DATEX-OHMEDA, INC. EXCEL 80 ANESTHESIA MACHINE Back to Search Results
Device Problem Computer Operating System Problem (2898)
Patient Problem No Patient Involvement (2645)
Event Date 10/31/2017
Event Type  malfunction  
Manufacturer Narrative
A gehc service representative performed a checkout of the equipment and confirmed the reported complaint. The adjustable pressure limit valve was cleaned and calibrated. 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 2001. The month of manufacture was unavailable at time of mdr filing.
 
Event Description
The hospital reported that, during the preoperative checkout, the adjustable pressure limit valve was not operating as expected. There was no report of patient involvement.
 
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Brand NameEXCEL 80
Type of DeviceANESTHESIA MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI
Manufacturer Contact
john szalinski
540 w. northwest highway
barrington, IL 
MDR Report Key7062772
MDR Text Key93498194
Report Number2112667-2017-02230
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K863207
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial
Report Date 11/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/28/2017
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 Received10/31/2017
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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