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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
Device Problem Energy Output Problem (1431)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/12/2020
Event Type  Malfunction  
Manufacturer Narrative

Unique identifier: (b)(4). No report of patient involvement. The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws. A ge healthcare service representative performed a checkout of the system and confirmed the reported issue. The drive gas check valve was replaced to resolve the reported issue.

 
Event Description

The hospital reported that the system was unable to drive the bellows resulting in a loss of mechanical ventilation. There was no report of patient involvement.

 
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Brand NameCARESTATION 650
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
MDR Report Key10500885
MDR Text Key205946703
Report Number9710602-2020-00268
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
PMA/PMN NumberK151570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Type of Report Initial
Report Date 09/08/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/08/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/12/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/10/2019
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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