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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 Device Tipped Over (2589)
Patient Problem No Patient Involvement (2645)
Event Date 01/23/2020
Event Type  malfunction  
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the system and confirmed the reported issue. The unit base and casters were replaced to resolve the reported issue. No report of patient involvement.
 
Event Description
The hospital reported a caster that came out of the base that could cause the unit to tip or fall. 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 53718
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key9701370
MDR Text Key182931190
Report Number2112667-2020-00422
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K092864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial
Report Date 02/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/08/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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