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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 Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2022
Event Type  malfunction  
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the system with the hospital biomed. Replacement of the cover manifold will be performed by hospital employee. 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)(6).
 
Event Description
The hospital reported a malfunction causing a leak greater than 4. 5lpm during pre-use checkout. 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
anthony amenson
3030 ohmeda drive
madison, WI 53718
MDR Report Key15005355
MDR Text Key295873668
Report Number2112667-2022-02158
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 Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 07/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/13/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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