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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE GE AVANCE CS2; SCAVENGING SYSTEM
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GE GE AVANCE CS2; SCAVENGING SYSTEM Back to Search Results
Device Problems Gas Output Problem (1266); Device Displays Incorrect Message (2591); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/13/2015
Event Type  Injury  
Event Description
On (b)(6) 2014, the ge avance cs2 (sn: (b)(4)) scavenging system malfunctioned while the machine was in-use on a pt.The cs2 sounded an audible alarm and displayed a "high peep blockage" error on the machine.This alarm was not indicative of the true problem, which was that the vacuum attachment for the waste gas scavenging system had been slightly dislodged from the base of the machine and waste gases were building.The crna who identified the problem, had seen this event occur in industry outside this facility and was only able to identify the problem due to past experiences.There is currently no sensor that detects changes in the scavenging system on the ge avance cs2.Pt surgery was delayed by 25 mins so did receive a longer anesthetic time than required.The company rep was in the operating room at the time and was troubleshooting this problem with staff.
 
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Brand Name
GE AVANCE CS2
Type of Device
SCAVENGING SYSTEM
Manufacturer (Section D)
GE
MDR Report Key4810364
MDR Text Key19819314
Report NumberMW5042861
Device Sequence Number1
Product Code BSZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/27/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age82 YR
Patient Weight88
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