MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) CARESTATION 620; ANESTHESIA GAS MACHINE

Device Problems Mechanical Problem (1384); Improper Flow or Infusion (2954)

Patient Problem No Patient Involvement (2645)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare¿s investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.(b)(4).Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported inverted flow.There was no report of patient involvement.

Manufacturer Narrative

It was initially reported that there were high co2 readings.Additional information has been received stating that there was no report of high co2 readings but that there was a complete loss of mechanical ventilation.A ge healthcare service representative confirmed the loss of mechanical ventilation.A flow sensor was replaced to resolve this issue.Update to device evaluation code.

• Brand Name: CARESTATION 620
• 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: 7499330
• MDR Text Key: 107754909
• Report Number: 9710602-2018-00113
• 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: 06/18/2018

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 BLOCK H10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 05/09/2018
• Supplement Dates Manufacturer Received: 05/30/2018
• Supplement Dates FDA Received: 06/18/2018
• 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