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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 Device Displays Incorrect Message (2591)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 01/08/2018
Event Type  malfunction  
Manufacturer Narrative
Ge healthcare issued a proposal for service and repair.The customer did not approve the proposal.The unit has been removed from service.No report of patient involvement.Date of device manufacture was unavailable at time of mdr filing.
 
Event Description
The hospital reported that there were several messages after self-test, vent error, vent communication error, o2 supply alarm failure.There was no report of patient involvement.
 
Manufacturer Narrative
Upon re-review of this event, it was concluded that because the system failed the self test, this condition prevents the system from being used.Ventilation can't be lost during use because the system can't be used.This is not a reportable malfunction.This event is not reportable.
 
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Brand Name
ADU
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
GE HEALTHCARE FINLAND OY
kuortaneenkatu 2
helsinki, FIN-0 0510
FI  FIN-00510
MDR Report Key7243784
MDR Text Key99102259
Report Number9610105-2018-00006
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,user facility
Type of Report Initial,Followup
Report Date 03/21/2018
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 01/08/2018
Initial Date FDA Received02/06/2018
Supplement Dates Manufacturer Received01/08/2018
Supplement Dates FDA Received03/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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