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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 Suction Failure (4039)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2020
Event Type  Malfunction  
Manufacturer Narrative

No report of patient involvement. Ge healthcare (gehc) became aware of an isolated customer contact platform which did not correctly categorize certain (b)(6) customer calls. Gehc investigation into the issue identified that some (b)(6) customer calls were not considered for complaint evaluation if the customer did not retain a service or warranty contract, and the customer also did not accept a quote for service from gehc. As part of gehc investigation, this specific call record was determined to be a reportable event and is being reported outside of the 30-day reporting timeline. This process non-conformance is being addressed via gehc capa system to: report any appropriate records/events which have not been reported as a result of this issue. Prevent future occurrence.

 
Event Description

The hospital reported a malfunction resulting in the loss of suction. 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
john szalinski
MDR Report Key12327868
MDR Text Key268208185
Report Number9710602-2021-00252
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK151570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 08/16/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/16/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/27/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/13/2019
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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