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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 Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Date 12/21/2016
Event Type  malfunction  
Manufacturer Narrative
The expiratory check valve was replaced. (b)(4).
 
Event Description
The hospital reported that, the unit failed the leak test and expiratory check valve was missing. There was no reported patient involvement.
 
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Brand NameCARESTATION 650
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda drive
madison WI
Manufacturer Contact
john szalinski
540 w. northwest highway
barrington, IL 
MDR Report Key6557865
MDR Text Key74840840
Report Number2112667-2017-00854
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 05/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2017
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 Received04/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/07/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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