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U.S. Department of Health and Human Services

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

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DATEX-OHMEDA, INC. AESPIRE VIEW ANESTHESIA GAS MACHINE Back to Search Results
Model Number 1009-9212-000
Device Problem Device Alarm System (1012)
Patient Problem No Patient Involvement (2645)
Event Date 12/04/2017
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer troubleshot this reported fault with ge healthcare technical support. The central processing unit was recommended for replacement. No report of patient involvement.
 
Event Description
The hospital reported the unit had an alarm that results in a loss of mechanical ventilation. There was no report of patient involvement.
 
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Brand NameAESPIRE VIEW
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key7154909
MDR Text Key96055318
Report Number2112667-2017-02425
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092864
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 12/29/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1009-9212-000
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 Received12/04/2017
Was Device Evaluated by Manufacturer? Yes
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

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