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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE FINLAND OY S/5 ADU CARESTATION ANESTHESIA GAS MACHINE

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GE HEALTHCARE FINLAND OY S/5 ADU CARESTATION ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Sticking (1597)
Patient Problem No Patient Involvement (2645)
Event Date 04/27/2018
Event Type  malfunction  
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the system and confirmed the reported issue. The adjustable pressure limit valve was replaced to resolve the reported issue. 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 the adjustable pressure limit valve was stuck. There was no report of patient involvement.
 
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Brand NameS/5 ADU CARESTATION
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
GE HEALTHCARE FINLAND OY
kuortaneenkatu 2
helsinki
FI
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key7540921
MDR Text Key109508052
Report Number9610105-2018-00019
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 05/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/17/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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