• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GE HEALTCARE AISYS GAS-MACHINE, ANESTHESIA Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAISYS
Type of DeviceGAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
GE HEALTCARE
8200 w tower ave
milwaukee WI 53223
MDR Report Key7227253
MDR Text Key98573104
Report Number7227253
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
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 Received01/30/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCS2
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/17/2018
Device Age5 YR
Event Location Hospital
Date Report to Manufacturer01/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/30/2018 Patient Sequence Number: 1
Treatment
ANESTHESIA MACHINE.
-
-