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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
Device Problem Detachment Of Device Component (1104)
Patient Problem No Patient Involvement (2645)
Event Date 08/09/2017
Event Type  Malfunction  
Manufacturer Narrative

A gehc service representative performed a checkout of the equipment and confirmed the reported complaint. The castor wheel and base were replaced. The unit was returned to service. 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.

 
Event Description

The hospital reported the unit's castor wheel fell out of the unit, causing the unit to tip. There was no report of injury.

 
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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
540 w. northwest highway
barrington, IL 
MDR Report Key6834298
MDR Text Key84126383
Report Number2112667-2017-01654
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
PMA/PMN NumberK092864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Type of Report Initial
Report Date 08/31/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/31/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/09/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/09/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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