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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESPIRE 7100 ANESTHESIA GAS MACHINE

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DATEX-OHMEDA, INC. AESPIRE 7100 ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/06/2022
Event Type  malfunction  
Event Description
The hospital reported a malfunction during pre-use checkout causing a leak greater than 4. 5 lpm. 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. (b)(4).
 
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Brand NameAESPIRE 7100
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
anthony amenson
MDR Report Key14945821
MDR Text Key295478454
Report Number2112667-2022-02090
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeMX
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 07/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/26/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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