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

Device Problem Tidal Volume Fluctuations (1634)

Patient Problem No Patient Involvement (2645)

Event Date 01/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.During ge healthcare technician checkout, it was found that the flow sensors and o2 cells were defective.The flapper of the flow sensor was stuck at the top of the housing.The mechanical ventilation was impacted and unit alarmed low tidal volume.The flow sensors and the o2 cells were replaced to fix the reported issue.

Event Description

The hospital reported that, unit randomly failed the pre-use tests.There was no reported patient involvement.

Manufacturer Narrative

Additional information was received confirming that the flapper valve in the flow sensor was not stuck open and that ventilation was still available despite the malfunction.This event is not a reportable malfunction.

• 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 ; CH
• Manufacturer Contact: joseph seliga ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 6307214
• MDR Text Key: 66772987
• Report Number: 9710602-2017-00024
• 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,Followup
• Report Date: 02/07/2017

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 H10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2017
• Initial Date FDA Received: 02/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2017
• 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