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

Model Number SERVO-S

Device Problem Tidal Volume Fluctuations (1634)

Patient Problems Tachycardia (2095); Low Oxygen Saturation (2477)

Event Date 07/04/2019

Event Type  Injury  

Event Description

It was reported that during patient treatment, the delivered tidal volume was lower than set level.The patient desaturated to 75 % and the heart rate increased to 155 bpm.The patient was disconnected from the ventilator and hand ventilated until a new ventilator was connected.The patient's vital signs gradually stabilized.Final patient outcome was no injury.Manufacturer¿s ref #: (b)(4).

Manufacturer Narrative

No service was requested and no parts were replaced.No ventilator logs were provided.Investigation consists of an evaluation of information received from the user facility the user facility explained that the ventilator passed pre-use check prior start of ventilation.During ventilation, alarms for low expiratory minute volume and technical error in expiratory cassette were generated.The ventilator was replaced and investigated.It was noted during the user facility investigation that the cleaning/disinfection procedures of the expiratory cassette had not been carried out in accordance with the user facility guidelines.In what way was not further communicated.After the expiratory cassette was cleaned according to user facility guidelines, it worked according to specification.The cleaning and maintenance user¿s manual of the ventilator clearly states the procedures for cleaning, disinfection and sterilization of the expiratory cassette.It has been reported that the user now is aware of the correct procedures.The alarms for low expiratory minute volume may be an indication of leakage leading to a loss of volume to the patient, but can also be a measuring error in the inappropriately cleaned expiratory cassette.The alarm technical error in expiratory cassette will not affect on-going ventilation, but the measured and monitored values may not be correct.The root cause of the reported delivered tidal volume lower than set level has not been conclusively determined but was most likely due to leakage.There are no indications of ventilator malfunction.The expiratory cassette is a measuring device in the expiratory section of the patient unit and will not affect ventilation.4117.

Event Description

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

• Brand Name: SERVO-S
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 9543984
• MDR Text Key: 174499752
• Report Number: 3013876692-2020-00001
• 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: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SERVO-S
• Device Catalogue Number: 6640440
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2020
• Distributor Facility Aware Date: 09/29/2020
• Device Age: 68 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2020
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening