• 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
Model Number 1009-9010-000
Device Problem Suction Failure (4039)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/12/2020
Event Type  malfunction  
Manufacturer Narrative
No report of patient involvement. Date of device manufacture year is 2004. The month of manufacture was unavailable at time of mdr filing. A ge healthcare service representative performed a checkout of the system and confirmed the reported issue. The suction regulator was replaced to resolve the reported issue.
 
Event Description
The hospital reported a malfunction resulting in the loss of suction. 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 53718
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key10970234
MDR Text Key220939861
Report Number2112667-2020-03413
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 12/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1009-9010-000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/12/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-