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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. CARESTATION 650; ANESTHESIA GAS MACHINE
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DATEX-OHMEDA, INC. CARESTATION 650; ANESTHESIA GAS MACHINE Back to Search Results
Model Number 1012-9650-000
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Patient Involvement (2645)
Event Date 07/31/2018
Event Type  malfunction  
Manufacturer Narrative
No report of patient involvement.(b)(4).A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The gas display board was replaced, the nitrous needle valve was zeroed, and the link 25 gas balancing system was calibrated.
 
Event Description
The hospital reported n20 being picked up on gas module with oxygen shut off.There was no report of patient involvement.
 
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Brand Name
CARESTATION 650
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 
MDR Report Key7813887
MDR Text Key118236246
Report Number2112667-2018-01682
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 08/24/2018
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
Device Model Number1012-9650-000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/31/2018
Initial Date FDA Received08/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/18/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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