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

Model Number SERVO-U

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 03/07/2021

Event Type  malfunction  

Event Description

It was reported that the ventilator at setup miscalculated the tidal volume and gave an inaccurate measurement of ml/kg on the screen.There was no patient harm.Manufacturer's ref #: (b)(4).

Event Description

Manufacturer's ref #: (b)(4).

Manufacturer Narrative

The inaccurate read vt/bw value is confirmed in the provided screen picture.During investigation it has been noted that when changing between ventilation modes, this value does not stay consistent.Although, the set parameter of tidal volume is maintained when reverting back to the previous mode the calculated vt/bw value changes.The calculation of the vt/bw value is incorrectly made on the last measured tidal volume instead of the tidal volume in previous mode.The error is temporary and as soon as there is an adjustment in the tidal volume settings, the vt/pbw value is corrected.The delivered tidal volume will always be correct as set.The inaccurate shown vt/bw value is a software related error and does not affect ventilation.This error has been corrected in system software version 4.1.For functionality enhancement, the latest released system software version is always recommended.

• Brand Name: SERVO-U
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: sara soderholm roman ; roentgenvagen 2; solna
• MDR Report Key: 11601969
• MDR Text Key: 243359592
• Report Number: 8010042-2021-00747
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SERVO-U
• Device Catalogue Number: 6694800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1