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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. CARESTATION 650 A1 ANESTHESIA GAS MACHINE

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DATEX-OHMEDA, INC. CARESTATION 650 A1 ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 01/09/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). A ge healthcare service representative performed a checkout of the system and confirmed the reported issue. The bag to vent switch was disassembled, lubricated, and reassembled to resolve the reported issue.
 
Event Description
The hospital reported that the bag to vent switch is stuck. There was no report of patient involvement.
 
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Brand NameCARESTATION 650 A1
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison WI 53718
Manufacturer Contact
joseph seliga
3000 n grandview blvd.
waukesha, WI 53188
2625443620
MDR Report Key7248112
MDR Text Key99233256
Report Number2112667-2018-00258
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 02/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2018
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 Received01/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/13/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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