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

Model Number SERVO-N

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem Hyperventilation (1910)

Event Date 12/22/2022

Event Type  Injury  

Event Description

It was reported that the patient connected to the ventilator, had a hyperventilation.Serious injury.Low level of co2.Final patient's outcome was unknown.Manufacturer's ref.#: (b)(4).

Event Description

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

Manufacturer Narrative

It was reported that during a neonatal patient transfer, the set tidal volume was not achieving in prvc mode.The circuit compliance factor is calculated during the patient circuit test performed before connecting the ventilator to a patient.By analyzing the logs, it was found that the circuit compliance factor was around 2.0 ml/cmh2o instead of approximately 1.4 ml/cmh2o which is the normal factor for the getinge neonatal patient circuit.As a result of this, the ventilator will in volume modes deliver more volume to compensate for the (faulty) higher compensation factor, and most of this will be delivered to the patient.The volumes presented on the ventilator will however show the volume calculated to reach the patient and not the actually delivered volume.A faulty circuit compliance factor will especially affect the patients with the smallest volumes, i.E.Neonates.The root cause for the wrongly calculated circuit compliance factor has not been possible determine other than it is some kind of use error.The correction of field #h8 usage of device was required.This is based on the internal evaluation.#h8 usage of device: previous usage of device: unknown.Corrected usage of device: reuse.

• Brand Name: SERVO-N
• 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: 16213878
• MDR Text Key: 307772447
• Report Number: 8010042-2023-00146
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K201874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SERVO-N
• Device Catalogue Number: 6688600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening