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

Model Number SERVO-U

Device Problem Failure to Deliver (2338)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 10/01/2019

Event Type  Injury  

Event Description

It was reported that the patient was ventilated on automode pressure control (apc) mode with pressure support (ps) and was stable cardiovascularly.On rolling, the ventilation stopped.The patient had hypotensive tachycardia, changed color and was switched to another ventilator.Final patient outcome was no injury.Manufacturer's ref #: (b)(4).

Manufacturer Narrative

The ventilator was investigated on-site by our field service engineer.The reported stop of ventilation could not be duplicated.No parts were replaced and the ventilator was cleared for clinical use.Ventilator logs were downloaded.At the reported date and time of the event, the event log confirms several clinical alarms have been generated, as an indication of difficulties with ventilating the patient.The logs show that the ventilator was set to pressure control ventilation mode and that alarms for airway pressure high and expiratory minute volume low were generated.Those alarms indicate that the ventilator was functioning and it attempted to deliver the set tidal volumes, but it failed due to the imposed restriction of the set upper pressure limit.This can be experienced as no gas flow is delivered thus generating the alarm expiratory minute volume low.It is noted in the event log that during the time the patient reportedly stopped being ventilated, the airway pressure alarm limit is decreased by the user to 21 cm h2o.This restricts the ventilator¿s ability to deliver the set pressure.The trend log shows that the ventilator continuously delivers flow and pressure until the time the airway pressure alarm limit is decreased by the user.Mode of ventilation is then changed to simv (pc) + ps where the ventilator delivers mandatory controlled breaths with a preset respiratory rate and pressure and delivers inspiratory support (ps) during spontaneous breaths taken between the mandatory breaths.The airway pressure alarm limit is not changed.Alarms for respiratory rate high are still generated.The technical log does not contain any technical error codes to indicate that there was a ventilator malfunction at the time of the event and the ventilator passed pre-use check prior ventilation was started.The conclusion is that there are no indications of ventilator malfunction during the ventilation period.The inability to ventilate the patient in pressure control mode after the manual ventilation was due to that the upper limit for airway pressure, chosen and set by the operator, was too low compared to set pressure parameters.This will lead to lower flow/volume than intended to the patient and that the ventilation may have been insufficient.The ventilator detected and alarmed for the situation.

Event Description

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

• Brand Name: SERVO-U
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 9213296
• MDR Text Key: 166746965
• Report Number: 3013876692-2019-00021
• 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: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2020
• Distributor Facility Aware Date: 02/14/2020
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2020
• Date Manufacturer Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening