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 Problem No Code Available (3191)

Event Date 10/03/2019

Event Type  Injury  

Event Description

It was reported that during patient treatment, ventilation stopped and alarms for low expiratory minute volume was generated.End tidal co2 measurements were lost.The patient was switched to another ventilator.Final patient outcome was no injury.Manufacturer's ref # : (b)(4).

Event Description

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

Manufacturer Narrative

The ventilator was investigated by field service engineer (fse).It was not possible to duplicate the reported event.No parts were replaced.The ventilator passed all safety and functional tests and was cleared for clinical use.Provided ventilator logs were reviewed.In the event log there are alarms for airway pressure high and expiratory minute volume low which were generated sporadically during the ventilation.However, the frequency of these alarms increased the last 10-12 minutes of the ventilation.The generated alarms for airway pressure high are an indication of high resistance in the patient circuit.When the alarm occurs, inspiration goes over to expiration and this will restrict the volume delivery to the patient.If the expired volume in the shortened breath falls below the set lower minute volume alarm limit, the expiratory minute volume low alarm will be generated.The trend log shows that the ventilator continuously delivered pressure and flow during the ventilation.During the last 10-12 minutes of ventilation the respiratory rate, inspiratory minute volume and leakage increased and the expiratory minute volume decreased which indicates a leakage.There are no technical error codes that indicate any technical issues with the ventilator.Pre-use checks prior and after the reported event were passed without remarks.The conclusion is that there are no indications of ventilator malfunction.The alarm generation indicates that the ventilation may have been insufficient.The logs indicate that a leakage occurred during the last 10-12 minutes of ventilation.The cause of the leakage has not been determined.

• Brand Name: SERVO-U
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 9214708
• MDR Text Key: 163055319
• Report Number: 3013876692-2019-00023
• 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