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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AISYS ANESTHESIA GAS MACHINE

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DATEX-OHMEDA, INC. AISYS ANESTHESIA GAS MACHINE Back to Search Results
Model Number 1011-9000-000
Device Problems Component Missing (2306); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Patient Involvement (2645)
Event Date 06/18/2019
Event Type  malfunction  
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the system and confirmed the reported issue. The ventilator interface board was replaced and software was reloaded to resolve the reported issue. No report of patient involvement. The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws. Date received by manufacturer: this mdr malfunction event was previously eligible for the voluntary malfunction summary reporting (vmsr) program. As of 9/16/2019 notification from fda, this product code is no longer eligible for vmsr. According to the notification, ge healthcare must submit individual reports within 30 calendar days of receiving the notification. Therefore, this event is being reported as an individual mdr report due 10/16/2019.
 
Event Description
The hospital reported an error stating that flow sensors are missing which prevents mechanical ventilation. There was no report of patient involvement.
 
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Brand NameAISYS
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer Contact
john szalinski
MDR Report Key9122693
MDR Text Key199909756
Report Number2112667-2019-00600
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K042154
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial
Report Date 09/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1011-9000-000
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/18/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/17/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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