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 11/27/2017

Event Type  malfunction  

Manufacturer Narrative

The ge healthcare service representative replaced the soda lime to resolve the reported issue.An incomplete seal can exist between the disposable absorber and the breathing circuit lower assembly of the carestation 600 series systems.This incomplete seal can allow rebreathing of patient gases that have bypassed the carbon dioxide (co2) absorbent material and could result in unintended elevated inspired levels of co2 (fico2), which could lead to hypercarbia.Ge healthcare initiated and reported a field modification for this issue per 21 cfr 806 on (b)(6) 2017.The gehc internal field modification number is fmi 34086.Block a: 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

A ge healthcare service representative reported etco2 high alarm message on screen.There was no report of patient involvement.

Manufacturer Narrative

The mdr follow-up #1 was submitted with the incorrect manufacturer report number 9710602-2017-00337.This mdr follow-up #2 is being submitted with the correct number 9710602-2017-00326.The mdr follow-up #1 was submitted with the incorrect manufacturer report number 9710602-2017-00337.This mdr follow-up #2 is being submitted with the correct number 9710602-2017-00326.

• 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: 7128787
• MDR Text Key: 96039267
• Report Number: 9710602-2017-00326
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 05/19/2020
• Supplement Dates FDA Received: 06/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 34086
• Patient Sequence Number: 1