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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESTIVA 7900 ANETHESIA MACHINE

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DATEX-OHMEDA, INC. AESTIVA 7900 ANETHESIA MACHINE Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/08/2018
Event Type  malfunction  
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint. The bag/vent microswitch was replaced, and the unit was returned to service. 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 a failure of the unit to switch to mechanical ventilation when requested, during patient use. There is no report of patient injury.
 
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Brand NameAESTIVA 7900
Type of DeviceANETHESIA MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison WI 53718
Manufacturer (Section G)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison WI 53718
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 53188
8479711808
MDR Report Key7244358
MDR Text Key99194410
Report Number2112667-2018-00248
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 Biomedical Engineer
Type of Report Initial
Report Date 02/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/22/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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