MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) CARESTATION 650 A1; ANESTHESIA GAS MACHINE

Device Problem Device Alarm System (1012)

Patient Problem No Patient Involvement (2645)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

There is no information available regarding device repair.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 in mechanical ventilation; the machine is going from 15 l/min to 1.5 l/min of fresh gas flow (fgf).The bellows would jam, no longer ventilating and indicating on the display the alarm "impossible to activate the bellows".There was no report of patient involvement.

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system and a review of the logs.The anesthesia control board (acb) was replaced to resolve the reported issue.

• Brand Name: CARESTATION 650 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 ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 7147911
• MDR Text Key: 95832139
• Report Number: 9710602-2017-00336
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• 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
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• 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