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

Model Number SERVO-I

Device Problem Output Problem (3005)

Patient Problem Death (1802)

Event Date 12/17/2020

Event Type  Death  

Event Description

It was reported that the ventilator was not delivering breaths to a patient.The patient died.Manufacturer's ref.#: (b)(4).

Event Description

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

Manufacturer Narrative

No service on the ventilator has been requested.The user facility performs service by themselves.Information about the current status of the ventilator has not been provided.Provided ventilator logs were reviewed.In the event log on the reported event date there are alarms for inspiratory flow overrange, peep low and check tubing.These alarms indicate a leakage in the patient breathing circuit.During the situation causing the alarms, the measured volume will be different than the set or expected volume.The technical log does not contain any technical error codes to indicate that there was a ventilator malfunction at the time of the event.In the test log, there is no successfully passed pre-use check prior ventilation was started.A pre-use check should always be performed before connecting the ventilator to a patient.The user performed a successful pre-use check after the event, which included a passed internal leakage test with a test tube.This indicates that the leakage was in the patient breathing circuit and not in the ventilator.The cause of the reported inability to deliver breaths to the patient was most likely a leakage in the patient breathing circuit.The cause of the leakage has not been determined.There are no indications of a ventilator malfunction.Correction of the fields #d4 serial # and #h4 device manufacture date was required.This is based on the internal evaluation.Previous serial #: (b)(6) corrected serial #: (b)(6) #h4 manufacture date: previous manufacture date: 06/16/2014 corrected manufacture date: 05/27/2005.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
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 11163631
• MDR Text Key: 226583482
• Report Number: 3013876692-2021-00002
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: VM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/21/2022
• Distributor Facility Aware Date: 10/20/2022
• Device Age: 17 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2022
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/27/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Weight: 3 KG