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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
Device Problems Device Tipped Over (2589); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/10/2019
Event Type  malfunction  
Manufacturer Narrative
Ge healthcare's investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.Patient information could not be obtained due to country privacy laws.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Device evaluation anticipated, but not yet begun.
 
Event Description
The hospital reported the caster wheel became detached resulting in the unit falling onto staff.There was no bruise, not cut to staff.No injury reported.
 
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.Replacement of the chassis and caster will be completed after covid-19 emergency to resolve the reported event.
 
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Brand Name
AISYS
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
MDR Report Key9563596
MDR Text Key198598290
Report Number2112667-2020-00076
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K172045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 04/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/10/2019
Initial Date FDA Received01/08/2020
Supplement Dates Manufacturer Received04/12/2020
Supplement Dates FDA Received04/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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