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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AVANCE CS2 ANESTHESIA GAS MACHINE

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DATEX-OHMEDA, INC. AVANCE CS2 ANESTHESIA GAS MACHINE Back to Search Results
Model Number 1009-9050-000
Device Problem Suction Failure (4039)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2020
Event Type  malfunction  
Manufacturer Narrative
No report of patient involvement. A ge healthcare service representative performed a checkout of the system and confirmed the reported issue. The internal suction tubing was pinched. This tubing was adjusted to remove the pinch which resolved the reported issue.
 
Event Description
The hospital reported a malfunction resulting in the loss of suction. There was no report of patient involvement.
 
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Brand NameAVANCE CS2
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer Contact
john szalinski
3030 ohmeda drive
madison, WA 
MDR Report Key11182939
MDR Text Key228420157
Report Number2112667-2021-00162
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172045
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 01/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1009-9050-000
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 Received12/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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