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

Model Number SERVO-U

Device Problems Contamination (1120); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

On-site investigation was performed by our field service engineer.The claimed issue was reproduced during troubleshooting.Based on technician statement, water entered the air gas module due to malfunctioning hospital's air central system.According to received service report, replacement of the air gas module solved the issue.The ventilator passed all functional and safety tests and was cleared for clinical use.The air gas module regulates the inspiratory gas flow and gas mixture.Moisture in the air gas module as previous investigation has shown, probably had affected the delta pressure transducer on a printed circuit board inside the gas module.The delta pressure transducer is part of the flow measuring in the gas module.The failure of the delta pressure transducer leads to inaccurate gas flow regulation which will be detected during pre-use check and alarms will be activated if the failure occurs during ventilation.The evaluation of received device's logs confirms occurrence of claimed internal leakage test failure on 26th february, 2024.Moreover, the flow transducer test, pressure transducer test and o2 sensor test failed as well.All pre-use check failures are a consequence of a faulty air gas module.The cause of the problem was related to malfunctioning hospital's air central system.However, the root cause to the reported issue has not been determined.

Event Description

It was reported that the ventilator failed internal leakage test during pre-use check.There was no patient involvement.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
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 18900996
• MDR Text Key: 337624842
• Report Number: 8010042-2024-00457
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07325710001110
• UDI-Public: (01)07325710001110(11)200609
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1