Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/18/2021
Event Type  malfunction  
Manufacturer Narrative
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.A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The flow sensors were replaced to resolve the reported issue.
 
Event Description
The hospital reported a leak from the flow sensors that may have been in excess of 4.5 lpm.There was no report of patient involvement.
 
Manufacturer Narrative
Additional information was received that the leak rate was less than 4.5l/min.A leak condition will be noted in the preop check of the equipment, as contained in the user manual.The leak may be able to be compensated for or made up with fresh gas flow.The event was not reportable.Additional information was received that the leak rate was less than 4.5l/min.A leak condition will be noted in the preop check of the equipment, as contained in the user manual.The leak may be able to be compensated for or made up with fresh gas flow.The event was not reportable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AVANCE
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
MDR Report Key11528493
MDR Text Key242754059
Report Number2112667-2021-00775
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K172045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 03/25/2021
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? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/18/2021
Initial Date FDA Received03/19/2021
Supplement Dates Manufacturer Received03/23/2021
Supplement Dates FDA Received03/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-