MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) CARESTATION 620 A1; ANESTHESIA GAS MACHINE

Device Problem Partial Blockage (1065)

Patient Problem No Patient Involvement (2645)

Event Date 09/25/2017

Event Type  malfunction  

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The air module with solenoid valve was replaced to resolve the issue.No report of patient involvement.(b)(4).

Event Description

The hospital reported the knob for the air is blocked; continuous flow maximum.There was no report of patient involvement.

• Brand Name: CARESTATION 620 A1
• 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 ; CH
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL
• MDR Report Key: 6958603
• MDR Text Key: 90556137
• Report Number: 9710602-2017-00256
• 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: 10/18/2017

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
• Other Device ID Number: SEE BLOCK H10
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2017
• Initial Date FDA Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2017
• 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