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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 Loss of Threshold (1633)
Patient Problem No Patient Involvement (2645)
Event Date 01/03/2018
Event Type  malfunction  
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the system and confirmed the reported issue. The compact block was replaced to resolve the reported issue.
 
Manufacturer Narrative
Ge healthcare's investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed. No report of patient involvement.
 
Event Description
The ge healthcare repair depot reported that the physical defect of the compact block would prevent use for any kind of operation. There was no report of patient involvement.
 
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Brand NameADU
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
GE HEALTHCARE FINLAND OY
kuortaneenkatu 2
helsinki, FIN-0 0510
FI FIN-00510
MDR Report Key7231587
MDR Text Key283942584
Report Number9610105-2018-00005
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 03/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/14/2018
Is This a Reprocessed and Reused Single-Use Device? No

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