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U.S. Department of Health and Human Services

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

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DATEX-OHMEDA, INC. AVANCE ANESTHESIA MACHINE; GAS-MACHINE, ANESTHESIA Back to Search Results
Device Problems Loss of Power (1475); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/20/2016
Event Type  malfunction  
Event Description
Biomed was informed by anesthesia staff that the ge avance anesthesia machine will go off-line and reboot when the equipment tower draw is closed hard.Bio-med conducted a test on 17 avance machines and 15 out of 17 stopped working and rebooted programming when the storage draw is closed harder than normal.Manufacturer response for avance anesthesia machine, avance anesthesia machine (per site reporter): bio-medical has spoken with ge healthcare and they are aware of the problem, but do not have a correction of issue at this time.
 
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Brand Name
AVANCE ANESTHESIA MACHINE
Type of Device
GAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3000 n grandview blvd
waukesha WI 53188
MDR Report Key5846322
MDR Text Key51152815
Report Number5846322
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Other Device ID NumberAPKT00848
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/25/2016
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer07/25/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO OTHER THERAPIES
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