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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 Sticking (1597)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/18/2018
Event Type  malfunction  
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the system and confirmed the reported issue. The bag to vent switch was replaced to resolve the reported issue. The customer contact reported there is no patient information available. Unique device identifier - (b)(4).
 
Event Description
The hospital reported that the bag / vent toggle sequence mechanically locked up during patient use. They could not physically move it all the way to the vent position. There was no report of patient injury.
 
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Brand NameCARESTATION 650
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 Key7517802
MDR Text Key108360113
Report Number2112667-2018-00975
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 05/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012-9650-000
Other Device ID NumberSEE BLOCK H10
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/17/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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