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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 Failure to Calibrate (2440)
Patient Problem No Patient Involvement (2645)
Event Date 08/03/2018
Event Type  malfunction  
Manufacturer Narrative
The customer biomed contacted ge healthcare technical support to confirm the part number for the sensor interface board.The correct part number was confirmed.The customer will replace the sensor interface board.No report of patient involvement.(b)(4).The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.
 
Event Description
The hospital reported that the unit was unable to perform flow and pressure calibration or a manifold p span calibration.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
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key7834665
MDR Text Key118876794
Report Number2112667-2018-01723
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K151570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial
Report Date 08/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2018
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
Was the Report Sent to FDA? No
Date Manufacturer Received08/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2017
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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