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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) CARESTATION 620 ANESTHESIA GAS MACHINE

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GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) CARESTATION 620 ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Computer Operating System Problem (2898)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2018
Event Type  malfunction  
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the system and confirmed the reported issue. A proposal for the defective part was submitted to customer and not accepted.
 
Manufacturer Narrative
No report of patient involvement. (b)(4). Ge healthcare's investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed.
 
Event Description
The hospital reported that the machine is not booting. There was no report of patient involvement.
 
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Brand NameCARESTATION 620
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)
no. 19 changjiang road
national hi-tech dev. zone
wuxi, 21402 8
CH 214028
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 53188
2625443620
MDR Report Key7224809
MDR Text Key175759439
Report Number9710602-2018-00027
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier00840682103985
UDI-Public010084068210398521SM616330018WA11160818
Combination Product (y/n)N
PMA/PMN Number
K151570
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 02/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/29/2018
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 Received02/02/2018
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 Unkown

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