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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 No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/07/2021
Event Type  malfunction  
Manufacturer Narrative
No patient information to date after calls to customer 07/29/2021, 08/02/2021, and 08/04/2021. Unique identifier: (b)(4). Ge healthcare's investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed.
 
Event Description
The hospital reported a complaint with an unspecified malfunction that may have caused a loss of mechanical ventilation. 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 (Section G)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer Contact
john szalinski
MDR Report Key12287389
MDR Text Key265371289
Report Number2112667-2021-01833
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,Followup
Report Date 09/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/06/2021
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/26/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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