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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) AESPIRE 7100 ANESTHESIA GAS MACHINE

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GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) AESPIRE 7100 ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Gas Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2021
Event Type  Malfunction  
Manufacturer Narrative

Patient information: no report of patient involvement. Ge healthcare (gehc) became aware of an isolated customer contact platform which did not correctly categorize certain (b)(6)-based customer calls. Gehcâs investigation into the issue identified that some (b)(6)-based 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 gehcâs 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 gehcâs 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 leak greater than 4. 5lpm. There was no report of patient involvement.

 
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Brand NameAESPIRE 7100
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 Key12327870
MDR Text Key268153363
Report Number9710602-2021-00253
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK172045
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 Received01/27/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/20/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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