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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 Problems Crack (1135); Gas Leak (2946)
Patient Problem No Patient Involvement (2645)
Event Date 12/30/2019
Event Type  Malfunction  
Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system. The absorber canister was replaced to resolve the reported issue. No report of patient involvement. (b)(4).

 
Event Description

The hospital reported a leak greater than 4. 5l/minute from a crack in the absorber canister during preuse checkout. There was no 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 Key9607055
MDR Text Key200784435
Report Number2112667-2020-00197
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 01/20/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/20/2020
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 Received12/31/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/03/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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