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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
Device Problem Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/27/2021
Event Type  malfunction  
Manufacturer Narrative
No report of patient involvement.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Unique identifier: (b)(4).Legal manufacturer: (b)(4).
 
Event Description
The hospital reported a leak greater than 4.5 lpm.There was no report of patient involvement.
 
Manufacturer Narrative
Additional information was received that the leak was less than 4.5lpm.A preop check of the machine, as contained in the user manual, will pick up such a condition.As stated in the report, the preop test failed, notifying the user of the reported condition.The leak may be able to be compensated for or made up with fresh gas flow.H3 other text : additional information was received that the leak was less than 4.5lpm.A preop check of the machine, as contained in the user manual, will pick up such a condition.As stated in the report, the preop test failed, notifying the user of the reported condition.The leak may be able to be compensated for or made up with fresh gas flow.
 
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Brand Name
AVANCE CS2
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
MDR Report Key12529423
MDR Text Key274471316
Report Number2112667-2021-02173
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K172045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 10/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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