MAUDE Adverse Event Report: GE HEALTCARE AISYS; GAS-MACHINE, ANESTHESIA

Model Number CS2

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 06/05/2017

Event Type  malfunction  

Event Description

Patient was being operated on.While the patient was connected to the anesthesia machine, the anesthesia physician connected his usb phone charger to one of the outputs of the cerner connectivity engine.This stopped hl7 data from flowing from the anesthesia machine to the cerner medical record.

• Brand Name: AISYS
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): GE HEALTCARE; 8200 w tower ave; milwaukee WI 53223
• MDR Report Key: 7227253
• MDR Text Key: 98573104
• Report Number: 7227253
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: CS2
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2018
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ANESTHESIA MACHINE.