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

Model Number SERVO-I

Device Problem Infusion or Flow Problem (2964)

Patient Problem Death (1802)

Event Date 07/18/2020

Event Type  Death  

Event Description

A user facility medwatch reference # (b)(4) was received stating that: "during ventilation of patient, an error alarm of low fio2 of 20% announced on patient with set fio2 of 80%.Patient started to brady down when sao2 dropped to >50%.Started cpr and 100 % ambu with peep valve.Vent settings 28/330/80/+10.Fio2 increased to 100 %.Some improvement.Patient remained hypotensive despite dose of levophed and albumin infusing, adding vasopressin.Heart rate drifted down, lost pulse.Patient expired.".

Event Description

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

Manufacturer Narrative

Further information regarding the ventilator and the event has been requested but no response has been received from the user facility.No ventilator logs have been provided and no service on the ventilator has been requested.Information about the current status of the ventilator has not been provided.No investigation has been possible, therefore the root cause of the reported event has not been determined.H3 other text: 4117.

• Brand Name: SERVO-I
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 10471111
• MDR Text Key: 204940907
• Report Number: 3013876692-2020-00043
• 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: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• 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: 09/17/2021
• Distributor Facility Aware Date: 09/17/2021
• Device Age: 44 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2021
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Weight: 98