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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 Failure to Cycle (1142)
Patient Problem No Patient Involvement (2645)
Event Date 07/10/2015
Event Type  malfunction  
Manufacturer Narrative
The drive gas check valve could become stuck in a fixed open position which could cause pressure to build in the mechanical ventilation cycle.If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.Ge healthcare (gehc) is initiating and will be reporting a field modification for this issue per 21 cfr 806.The gehc internal field modification number is (b)(4).
 
Event Description
The hospital reported an unable to drive bellows alarm in volume vent mode.There was no report of patient involvement.
 
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Brand Name
AVANCE CS2
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda drive
madison WI 53718
Manufacturer (Section G)
DATEX-OHMEDA, INC.
3030 ohmeda drive
madison WI 53718
Manufacturer Contact
john szalinski
540 w. northwest highway
barrington, IL 60010
MDR Report Key5315655
MDR Text Key34765894
Report Number2112667-2015-00432
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Biomedical Engineer
Remedial Action Recall
Type of Report Initial
Report Date 07/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/30/2015
Date Device Manufactured04/22/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Removal/Correction NumberFMI 34071
Patient Sequence Number1
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