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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
Model Number 1009-9212-000
Device Problem Energy Output Problem (1431)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/12/2018
Event Type  malfunction  
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint.The unit was re-calibrated and the breathing system was cleaned.The unit was returned to service.The customer contact reported there is no patient information available.(b)(4).
 
Event Description
The hospital reported the unit alarmed and lost the ability to mechanically ventilate.There was no report of patient injury.
 
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Brand Name
AESPIRE VIEW
Type of Device
ANESTHESIA 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 Key8175091
MDR Text Key130793367
Report Number2112667-2018-02505
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092864
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 12/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1009-9212-000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/16/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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