MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB BASE UNIT SERVO-U; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 6694800

Device Problems Device Alarm System (1012); No Display/Image (1183); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2022

Event Type  malfunction  

Event Description

From event report provided by registered respiratory therapist (rrt): "very loud audible alarm coming from the ventilator.Rn noticed that the bottom row of data (settings row) grayed out.This rrt called to bedside.Rn immediately disconnected patient from ventilator and began bagging so troubleshooting could occur.Back pressure from boom resulting in o2 hose popping out of connector multiple times.Loud alarm would only stop if ventilator turned completely off.Planned to extubate patient later in evening, apn and md at bedside and proceeded with extubation to high flow nasal cannula." this issue was identified by getinge as a potential issue in summer of 2022.In fall of 2022, our fleet of ventilators had a software update applied that was intended to mitigate the issue.Since this software upgrade, we have experienced 3 total events that align with the original device correction notice.Of note, we have had these ventilators since spring of 2021 and have not ever experienced this issue until the software upgrade was applied in fall of 2022.Biomed supervisor, further noted in his report to the oem, "confirmed technical error 55 and technical error 28.The user described the issue as follows: "continuous high pitched alarm, o2 hose back pressure, bottom of the screen blacked out".I could not duplicate these symptoms or the error codes.Pre-use check passed.Alarms were not sounding outside of alarm conditions.*i¿m not sure what they meant by ¿o2 hose back pressure¿, i did not see any issue with the hose, quick connect, or anything else to do with the o2 hose.*this vent is a little different because they specifically reported that the bottom of the screen blacked out and in the other 2 instances the users reported that the whole screen blacked out.Base unit servo-u" response from getinge tech support: replace the control cable.There is bad communication between user interface and patient unit.When pc1992 tries to generate an alarm, it cannot verify that the alarm sounds as that is in the user interface and that verification signal does not reach pc1992.And to generate the alarm it have to use the buzzer so te55 is the primer alarm to address te28 just a result of that alarm" manufacturer response for ventilator, continuous, facility use, base unit servo-u (per site reporter) there is bad communication between user interface and patient unit.When pc1992 tries to generate an alarm, it cannot verify that the alarm sounds as that is in the user interface and that verification signal does not reach pc1992.And to generate the alarm it have to use the buzzer.So te55 is the primer alarm to address te28 just a result of that alarm.

• Brand Name: BASE UNIT SERVO-U
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; 45 barbour pond dr; wayne NJ 07470
• MDR Report Key: 16214046
• MDR Text Key: 307782027
• Report Number: 16214046
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 6694800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2022
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 8 DA
• Patient Sex: Female