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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 Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/22/2017
Event Type  malfunction  
Manufacturer Narrative
A gehc service representative performed a checkout of the equipment and a review of the logs.The unit was found to function within manufacturer's specifications.Patient information could not be obtained after multiple attempts.Attempts were made as follows: 01/12/18 phone call, 01/16/18 phone call, 01/17/18 phone call.
 
Event Description
The hospital reported that, during a case, the unit went into alt o2 mode.Clinician reportedly switched to manual mode to maintain ventilation.There was no reported patient injury.
 
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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
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key7204733
MDR Text Key97900538
Report Number2112667-2018-00164
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 Nurse
Type of Report Initial
Report Date 01/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 12/22/2017
Initial Date FDA Received01/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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