MAUDE Adverse Event Report: GE HEALTHCARE AISYS CARESTATION; GAS MACHINE, ANESTHESIA

Model Number AISYS CARESTATION

Device Problems Device Alarm System (1012); Partial Blockage (1065); Computer Software Problem (1112)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2014

Event Type  malfunction  

Event Description

Upon turning the patient to the prone position, the endotracheal (et) tube became blocked.Clinicians did not observe any alarms from the anesthesia machine for well over 1 minute, during which time the patient was not being ventilated.Staff could tell from the display there was a problem, and corrected the obstruction before any injury occurred.This appears to be an issue with the software.When using the pcv-vg ventilator mode, if the et tube becomes kinked or obstructed, the alarm sequence is different than the other modes.All our aisys machines behave the same way.In the other modes such as vcv or simv/psv mode, if the et tube is obstructed, the alarm goes off in about 5 seconds with flashing red on the screen and a rapid 5 beep alarm every 10 seconds.This is hard to miss.In pcv-vg mode, if the et tube is obstructed, the first alarm does not appear for 45 seconds, and is a single beep with 'tv not achieved' message, no flashing.After another 45 seconds, a second alarm 'mv low' and 3 beeps every 30 seconds appears.It is very easy to miss the single beep of the first alarm.The second alarm is not flashing red and would be easy enough to miss the first time.Clinicians report there have been several near-miss events caused by this problem.
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manufacturer response for anesthesia machine, (brand not provided) (per site reporter).
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issue is under investigation.

• Brand Name: AISYS CARESTATION
• Type of Device: GAS MACHINE, ANESTHESIA
• Manufacturer (Section D): GE HEALTHCARE; 9900 w. innovation drive,; rp2138; wauwatosa, WI 53226
• MDR Report Key: 4029800
• MDR Text Key: 15121263
• Report Number: 4029800
• Device Sequence Number: 1
• Product Code: BSZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/11/2014

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: Physician
• Device Model Number: AISYS CARESTATION
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/11/2014
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 57 YR