• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DATEX-OHMEDA, INC. AVANCE ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 01/24/2018
Event Type  malfunction  
Manufacturer Narrative
A gehc service representative performed a checkout of the equipment and confirmed the reported complaint. The tubing between the auxiliary oxygen socket and the regulator was replaced. 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.
 
Event Description
The hospital reported the auxiliary flowmeter is not working as expected. There was no report of patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAVANCE
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha 
MDR Report Key7286680
MDR Text Key100777125
Report Number2112667-2018-00384
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K032803
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial
Report Date 02/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-