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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 Leak/Splash (1354); Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/15/2019
Event Type  Malfunction  
Manufacturer Narrative

There was no ge employee visit to this site, therefore the repair is unknown. Patient information could not be obtained due to country privacy laws. Unique identifier: (b)(4). The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws.

 
Event Description

Reported via (b)(6) aer database, the hospital reports loss of mechanical ventilation due to air leak during a case. No patient injury reported.

 
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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 Key9559629
MDR Text Key220287660
Report Number2112667-2020-00064
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 01/07/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/07/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/16/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/14/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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