MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) AESPIRE 7100; ANESTHESIA GAS MACHINE

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Patient Involvement (2645)

Event Date 08/11/2018

Event Type  malfunction  

Manufacturer Narrative

The ge healthcare service representative performed a checkout of the equipment and confirmed the mylar flap of the flow sensors were stuck to the top of the flow sensor housing.The flow sensors was replaced, and the unit was returned to service.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

The hospital reported the tidal volume is not being displayed accurately.There was no report of patient involvement.

• Brand Name: AESPIRE 7100
• 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 Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 7856058
• MDR Text Key: 119803607
• Report Number: 9710602-2018-00227
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K000706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial
• Report Date: 09/07/2018

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/11/2018
• Initial Date FDA Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2012
• 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