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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) CARESTATION 650; ANESTHESIA GAS MACHINE
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GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) CARESTATION 650; ANESTHESIA GAS MACHINE Back to Search Results
Model Number 1012-9650-000
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Patient Involvement (2645)
Event Date 06/12/2018
Event Type  malfunction  
Manufacturer Narrative
No report of patient involvement.(b)(4).A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The anesthesia control board and the power management board were replaced to resolve the reported issue.
 
Event Description
The hospital reported multiple internal system communication errors.There was no report of patient involvement.
 
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Brand Name
CARESTATION 650
Type of Device
ANESTHESIA 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 (Section G)
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
8479711808
MDR Report Key7677409
MDR Text Key113757779
Report Number9710602-2018-00182
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier00840682103947
UDI-Public01008406821039472
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 07/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1012-9650-000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/02/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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