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

Device Problems Device Alarm System (1012); Device Stops Intermittently (1599); Invalid Sensing (2293); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information could not be obtained due to country privacy laws.(b)(4).The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Ge healthcare¿s investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported that, the scavenging sensor in various operating room showed different values.In urology room, the alarm activates intermittently at 45 lt/min, while in surgery room, the alarm is permanently active at 55 lt/min.There was no reported patient injury.

Manufacturer Narrative

The ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The software was updated to service pack 04 to resolve the reported issue.

Manufacturer Narrative

Ge healthcare product engineering reviewed this event and determined that this issue will not impact the machine function and ventilation will not be impacted.Thus, this case has been assessed as not reportable.

• 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: 6247686
• MDR Text Key: 65090206
• Report Number: 9710602-2017-00005
• 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,Followup
• Report Date: 01/12/2017

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: 12/14/2016
• Initial Date FDA Received: 01/12/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/14/2017; 04/19/2017
• 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