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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
Model Number 1012-9650-000
Device Problem Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Date 08/08/2019
Event Type  malfunction  
Manufacturer Narrative
A ge healthcare service representative replaced the overflow trap to resolve the issue. No report of patient involvement. Date received by manufacturer: this mdr malfunction event was previously eligible for the voluntary malfunction summary reporting (vmsr) program. As of 9/16/2019 notification from fda, this product code is no longer eligible for vmsr. According to the notification, ge healthcare must submit individual reports within 30 calendar days of receiving the notification. Therefore, this event is being reported as an individual mdr report due 10/16/2019.
 
Event Description
A ge healthcare service representative reported that the overflow trap was missing on a demo unit. 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
john szalinski
MDR Report Key9109073
MDR Text Key199889576
Report Number2112667-2019-00476
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier00840682103947
UDI-Public010084068210394721
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 foreign,health professional,u
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 09/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2019
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 Received08/08/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/27/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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