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

Model Number SERVO-N

Device Problem Failure to Deliver (2338)

Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)

Event Date 08/24/2020

Event Type  Injury  

Event Description

It was reported that during patient treatment, there was no flow or volume from the ventilator.Alarms for low expiratory minute volume were generated.The patient desaturated and became bradycardic.The ventilator was disconnected and the patient was manually bagged until the ventilator was connected again.Final patient outcome was no injury.Manufacturer's ref #: (b)(4).

Manufacturer Narrative

Further information was requested but no response has been received.No ventilator logs have been provided and no service on the ventilator has been requested.Information about the current status of the ventilator has not been provided.Some screen shots were provided showing no measured flow (and hence volume) with generated alarm for low expiratory minute volume as described.There is no increase in pressure in the screen shots.Ventilation mode is set to pressure regulated volume control (prvc) where the ventilator delivers a preset tidal volume.The pressure is automatically regulated to deliver this volume but limited to 5 cm h2o below the set upper pressure limit.In the prvc algorithm in the software version used in the subjected ventilator, breaths with extremely small measured compliance are excluded from the calculations for the pressure level of the next breath.The pressure then does not increase from breath to breath, even though delivered volume is too low.A possible explanation may be a total occlusion of the endotracheal tube on a small patient with a significant amount of secretions in the airways.Without the pressure increase, the mucus may not be cleared from the endotracheal tube, and hence the situation will remain until higher pressures are applied, e.G.Through hand bagging, or switching to a pressure control mode with higher peak pressures.Newer software version include these breaths with extremely small measured compliance, but limit the measured compliance in the calculation of the pressure level for the next breath, resulting in a gradual increase in pressure also in the situation of a total endotracheal tube occlusion.This would most likely within a few breaths resolve a situation where mucus is blocking the endotracheal tube.Our conclusion is that a problem occurred in the breathing circuit system, an occlusion of the endotracheal tube affecting the flow and volume to the patient.It was detected by the ventilator and alarms were generated.There is no indication of ventilator malfunction.

Event Description

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

• Brand Name: SERVO-N
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 10579409
• MDR Text Key: 208307787
• Report Number: 3013876692-2020-00049
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SERVO-N
• Device Catalogue Number: 6688600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2021
• Distributor Facility Aware Date: 03/25/2021
• Device Age: 21 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2021
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 3 DA