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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE FINLAND OY ADU; ANESTHESIA GAS MACHINE
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GE HEALTHCARE FINLAND OY ADU; ANESTHESIA GAS MACHINE Back to Search Results
Device Problems Partial Blockage (1065); Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 06/26/2017
Event Type  malfunction  
Manufacturer Narrative
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.Ge healthcare¿s investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Device evaluation anticipated, but not yet begun.
 
Event Description
The hospital reported the ventilator block.There was no reported patient involvement.
 
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The anesthetic gas scavenging system (agss) assembly was disassembled and reassembled and the system now works correctly.
 
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Brand Name
ADU
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
GE HEALTHCARE FINLAND OY
kuortaneenkatu 2
helsinki
FI 
Manufacturer Contact
joseph seliga
3000 n grandview blvd.
waukesha, WI 
MDR Report Key6736640
MDR Text Key81048915
Report Number9610105-2017-00048
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K050676
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 08/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2017
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
Date Manufacturer Received06/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/1970
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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