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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 Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/26/2024
Event Type  malfunction  
Event Description
It was reported that there was a malfunction resulting in loss of manual ventilation.There was no patient involvement.
 
Manufacturer Narrative
Ge healthcares investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.A: no report of patient involvement.Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.
 
Manufacturer Narrative
Additional information was received that the damage to the adjustable pressure limiting valve was superficial and did not cause loss of manual ventilation.There was no reportable malfunction.
 
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Brand Name
AVANCE
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer (Section G)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer Contact
anthony amenson
3030 ohmeda drive
madison, WI 53718
MDR Report Key18980009
MDR Text Key338619125
Report Number2112667-2024-01628
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K172045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 04/04/2024
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/26/2024
Initial Date FDA Received03/26/2024
Supplement Dates Manufacturer Received04/04/2024
Supplement Dates FDA Received04/04/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/15/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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