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

Model Number SERVO-I

Device Problem Failure to Deliver (2338)

Patient Problem Death (1802)

Event Date 09/30/2020

Event Type  Injury  

Event Description

It was reported that during ambulance transport, there was a stop of ventilation.The patient complications following the reported stop of ventilation is unknown.The patient then died after a few days of hospitalization.Cause and date of death is unknown.It is unknown if the patient was connected to the subjected ventilator in the ambulance or when expired.Manufacturer's ref #: (b)(4).

Event Description

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

Manufacturer Narrative

The ventilator reportedly stopped ventilation in an ambulance on unknown date.The patient later died at the hospital reportedly on (b)(6) 2020.The ventilator was investigated by our field service engineer.No faults were found and no parts were replaced.The ventilator passed all safety and functional tests.Provided ventilator logs were reviewed.Since the ventilator has been in use after the event, the registrations from unknown event date and the date when patient expired are overwritten in the event log.The earliest log post is from on (b)(6) 2020.The technical log does not contain any technical error codes to indicate that there was a ventilator malfunction at the time of the event.The ventilator passed pre-use check on sep 27, 2020.Since the event date in the ambulance has not been clarified, it is unknown if this is prior or after the reported stop of ventilation.As a conclusion, since the ventilator has been in use after the event and the event log has been overwritten, the reported stop of ventilation has not been able to be determined.Based on review of the technical log and ventilator testing there is no ventilator malfunction.

• Brand Name: SERVO-I
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 10822376
• MDR Text Key: 217942275
• Report Number: 3013876692-2020-00057
• 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: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SERVO-I
• Device Catalogue Number: 6487800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2021
• Distributor Facility Aware Date: 09/20/2021
• Device Age: 12 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2021
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening