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

Model Number SERVO-U

Device Problem Infusion or Flow Problem (2964)

Patient Problem Respiratory Acidosis (2482)

Event Date 12/12/2020

Event Type  Injury  

Event Description

It was reported that during patient treatment, the ventilator delivered lower minute volume than set.The patient¿s ph level decreased to 6.9.The ventilator was replaced and the patient recovered from the low ph rapidly.Final patient outcome was no injury.Manufacturer¿s ref #: (b)(4).

Manufacturer Narrative

The ventilator was investigated by our field service engineer.The patient circuit and expiratory cassette used during the event was not available.Tests was performed with new patient circuit and expiratory cassette.No fault was found and the ventilator passed pre-use check.No parts were replaced.The ventilator was then returned to clinical use.Provided ventilator logs were reviewed.The logs indicate alarms for leakage in the patient breathing circuit or a disconnect situation; expiratory minute volume and peep low.Successful pre-use check was performed prior and after the event date.The technical log does not contain any technical error codes to indicate that there was a ventilator malfunction at the time of the event.There is no indication of ventilator malfunction at the time of event.The cause of the alarms has not been determined but they were most probably due to leakage.

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: 11155380
• MDR Text Key: 226284799
• Report Number: 3013876692-2021-00001
• 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: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 09/27/2021
• Distributor Facility Aware Date: 09/24/2021
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2021
• Supplement Dates Manufacturer Received: 09/24/2021
• Supplement Dates FDA Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening