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

Device Problem High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system but was unable to reproduce the reported issue.The co2 absorber had been changed and the original was not retained.Ge healthcare initiated and reported a field modification for this issue per 21 cfr 806 on october 18, 2017.The fda report number for this recall is z-0579-2018.Patient information could not be obtained due to country privacy laws.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 elevated co2 readings.There was no report of patient injury.

• 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, 21402 8; CH 214028
• Manufacturer (Section G): GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI); no. 19 changjiang road; national hi-tech dev. zone; wuxi, 21402 8; CH 214028
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI 53188 ; 8479711808
• MDR Report Key: 7560120
• MDR Text Key: 109754945
• Report Number: 9710602-2018-00141
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 00840682103947
• UDI-Public: 01008406821039471
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/21/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0579-2018
• Patient Sequence Number: 1