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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 Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 05/29/2018
Event Type  Malfunction  
Manufacturer Narrative

No report of patient involvement. A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint. The co2 absorbent canister was replaced, and the unit was returned to service.

 
Event Description

The hospital reported the unit was not holding pressure. 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
joseph seliga
3000 n grandview blvd.
waukesha, WI 
MDR Report Key7648059
MDR Text Key112722764
Report Number2112667-2018-01295
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK092864
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 06/28/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/28/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received05/29/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/20/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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