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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. S/5 AESTIVA UNSPECIFIED ANESTHESIA GAS MACHINE

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DATEX-OHMEDA, INC. S/5 AESTIVA UNSPECIFIED ANESTHESIA GAS MACHINE Back to Search Results
Model Number M1156192
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/21/2018
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer troubleshot this reported fault with ge healthcare technical support. The flow valves were recommended for replacement. Patient information could not be obtained after multiple attempts. Attempts were made as follows: (b)(6) 2018 phone call, (b)(6) 2018 phone call, (b)(6) 2018 phone call.
 
Event Description
The hospital reported the unit was not allowing the patient to exhale during a case. There was no report of patient injury.
 
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Brand NameS/5 AESTIVA UNSPECIFIED
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key7286146
MDR Text Key100660846
Report Number2112667-2018-00378
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K023366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 02/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM1156192
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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