MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) CARESTATION 650; ANESTHESIA GAS MACHINE

Device Problems Loss of Power (1475); Self-Activation or Keying (1557)

Patient Problem No Patient Involvement (2645)

Event Date 09/20/2018

Event Type  malfunction  

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The power management board was replaced to resolve the reported issue.No report of patient involvement.(b)(4).

Event Description

The hospital reported that the unit shut down on its own.There was no report of patient involvement.

• Brand Name: CARESTATION 650
• 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 Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 7975620
• MDR Text Key: 124336891
• Report Number: 9710602-2018-00268
• Device Sequence Number: 1
• Product Code: BSZ
• 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,health professional,u
• Type of Report: Initial
• Report Date: 10/17/2018

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2018
• Initial Date FDA Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1