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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESPIRE 7900; ANESTHESIA GAS MACHINE
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DATEX-OHMEDA, INC. AESPIRE 7900; ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Inaccurate Delivery (2339)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/21/2022
Event Type  malfunction  
Event Description
The hospital reported a malfunction that could cause a hypoxic mixture in the patient circuit.There was no report of patient involvement.
 
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).
 
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Brand Name
AESPIRE 7900
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
MDR Report Key14149665
MDR Text Key289732512
Report Number2112667-2022-00942
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeEG
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 04/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2022
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
Was the Report Sent to FDA? No
Date Manufacturer Received03/21/2022
Date Device Manufactured09/22/2010
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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