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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AVANCE; ANESTHESIA GAS MACHINE
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DATEX-OHMEDA, INC. AVANCE; ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Tidal Volume Fluctuations (1634)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/07/2017
Event Type  malfunction  
Manufacturer Narrative
The hospital biomed reported he will replace the drive gas check valve.Patient information could not be obtained after multiple attempts.Attempts were made as follows: 3/22/17 phone call, 3/27/17 phone call, 4/4017 phone call.
 
Event Description
The hospital reported that, during a case, the unit was delivering higher tidal volume than expected.The clinician reportedly disconnected the patient circuit to release the pressure.The circuit was reconnected and the case was completed with no further reported complaint.There was no reported patient injury.
 
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Brand Name
AVANCE
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda drive
madison WI
Manufacturer Contact
john szalinski
540 w. northwest highway
barrington, IL 
MDR Report Key6460425
MDR Text Key71723882
Report Number2112667-2017-00634
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032803
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 04/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2017
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 Received03/07/2017
Date Device Manufactured10/05/2009
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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