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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 Problem Improper Flow or Infusion (2954)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/15/2017
Event Type  malfunction  
Manufacturer Narrative
No further information on the repairs since customer decided to fix himself.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.No further information on the repairs since customer decided to fix himself.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.
 
Event Description
The hospital reported that, during self-test and operation; the ratio between oxygen and air is not regulated correctly.There was no reported patient injury.
 
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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
john szalinski
540 w. northwest highway
barrington, IL 
MDR Report Key6629703
MDR Text Key77403982
Report Number9610105-2017-00039
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
Report Date 06/09/2017
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? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/15/2017
Initial Date FDA Received06/09/2017
Date Device Manufactured10/08/2001
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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