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

Device Problems Obstruction of Flow (2423); Noise, Audible (3273)

Patient Problems No Patient Involvement (2645); No Code Available (3191)

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

Check valve was replaced to fix the reported issue.(b)(4).

Event Description

The hospital reported that, earlier the unit had fault in the ventilator and gave unexpected peep, without giving alarms of "high peep, there is an obstruction¿.The device was taken off use after engineer's request.There was not harm to the patient.The ventilation problem occurred again on the same device.The pressure in the circuit reached approximately 10 cm/h2o.There was no reported patient involvement.

• 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 ; 540 w. northwest highway; barrington, IL
• MDR Report Key: 6304770
• MDR Text Key: 67090003
• Report Number: 9710602-2017-00023
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• 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: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• 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
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2016
• 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