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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
Model Number 1009-9012-000
Device Problem Improper Flow or Infusion (2954)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2021
Event Type  malfunction  
Manufacturer Narrative
No report of patient involvement. A ge healthcare service representative performed a checkout of the system and confirmed the reported issue. The proportional valve was replaced to resolve the reported issue.
 
Event Description
The hospital reported the gas proportioning system was not operating as expected, causing the potential of a hypoxic mix of gas delivery. There was no report of patient involvement.
 
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Brand NameAESPIRE 7900
Type of DeviceANESTHESIA 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
john szalinski
MDR Report Key12260268
MDR Text Key266590566
Report Number2112667-2021-01812
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172045
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 08/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1009-9012-000
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 Received07/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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