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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 Suction Failure (4039)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2021
Event Type  malfunction  
Manufacturer Narrative
No patient information available. Unique identifier: (b)(4). A ge healthcare service representative performed a checkout of the system and confirmed the reported issue. The suction canister was cleaned to resolve the reported issue.
 
Event Description
The hospital reported a malfunction resulting in the loss of suction. 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 53718
Manufacturer Contact
john szalinski
MDR Report Key11328297
MDR Text Key232425612
Report Number2112667-2021-00406
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 02/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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
Event Location No Information
Date Manufacturer Received01/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/09/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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