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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 Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/23/2022
Event Type  malfunction  
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the system and found that, following a restart of the device, had corrected the reported issue. The service representative reviewed the logs and did find an error had occurred, however the issue was no longer present. No report of patient involvement. Unique identifier:(b)(6). The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws. Legal manufacturer: (b)(4).
 
Event Description
The customer reported a malfunction resulting in the loss of display. 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 (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
anthony amenson
3030 ohmeda dr.
madison, WI 53718
MDR Report Key15077924
MDR Text Key303064946
Report Number9710602-2022-00357
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K151570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 07/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/15/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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