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

Device Problems Defective Device (2588); Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/31/2022

Event Type  malfunction  

Event Description

Servo-u ventilator system alarmed "disconnect" but was not disconnected.Ventilator screen showed patient not receiving breathing assistance.Patient disconnected from servo-u ventilator and bagged.Message on ventilator then read "error, replace vent immediately." new servo-u ventilator was brought and patient oxygen saturation did recover once disconnected from malfunctioning ventilator.

• 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: 15485049
• MDR Text Key: 300586621
• Report Number: 15485049
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA