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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE AVANCE; ANESTHESIA GAS MACHINE
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GE HEALTHCARE AVANCE; ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Energy Output Problem (1431)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/19/2022
Event Type  malfunction  
Manufacturer Narrative
Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.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.Legal manufacturer: (b)(4).
 
Event Description
It was reported that there was an error resulting in a loss of mechanical ventilation.There was no patient involvement.
 
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Brand Name
AVANCE
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
GE HEALTHCARE
3030 ohmeda dr.
madison WI 53718
Manufacturer (Section G)
GE HEALTHCARE
3030 ohmeda dr.
madison WI 53718
Manufacturer Contact
anthony
3030 ohmeda dr.
madison, WI 53718
6086223124
MDR Report Key15826060
MDR Text Key307692159
Report Number2112667-2022-04827
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeIT
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
Report Date 11/18/2022
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? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/19/2022
Initial Date FDA Received11/18/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/08/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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