MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) CARESTATION 620; ANESTHESIA GAS MACHINE

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 01/10/2018

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.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.

Event Description

The hospital reported that the unit would not connect.There was no report of patient involvement.

Manufacturer Narrative

Additional information was received stating that the system would not turn on because of a defective power supply.Because the unit would not turn on, use of the device was not possible.Because use of the unit was not possible, this was not a reportable malfunction.Additional information was received stating that the system would not turn on because of a defective power supply.Because the unit would not turn on, use of the device was not possible.Because use of the unit was not possible, this was not a reportable malfunction.

• Brand Name: CARESTATION 620
• 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 Key: 7251924
• MDR Text Key: 99801007
• Report Number: 9710602-2018-00033
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 00840682103985
• UDI-Public: 01008406821039859
• Combination Product (y/n): N
• PMA/PMN Number: K151570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 02/08/2018
• Supplement Dates Manufacturer Received: 04/10/2018
• Supplement Dates FDA Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/1970
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1