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

Model Number SERVO-U

Device Problems Leak/Splash (1354); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2021

Event Type  malfunction  

Event Description

It was reported that the ventilator was leaking and making noise while ventilating.There was no patient harm.(b)(4).

Event Description

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

Manufacturer Narrative

The ventilator was investigated at site by our field service engineer.It was reported that the ventilator was making noise while ventilating.The nozzle unit in the gas modules were found defective.The nozzle unit of the gas modules and the inspiratory pipe were replaced.After replacement of the nozzle units, the ventilator passed all functional and safety tests and was cleared for clinical use.The provided logs revealed clinical alarms at the event most likely due to leakage.The nozzle unit is part of the gas module and regulates the inspiratory gas flow to the patient.It consists of a membrane, a mouthpiece and a feather spring.The membrane in the nozzle unit is pressed against a mouthpiece with a feather spring to regulate the gas flow through the gas module.The replaced nozzle units were not returned for investigation, therefor the root cause for the reported problem could not be determined.

• 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: sara soderholm roman ; roentgenvagen 2; solna
• MDR Report Key: 11377505
• MDR Text Key: 233443147
• Report Number: 8010042-2021-00490
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K180098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 12/10/2021
• Supplement Dates FDA Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2020
• 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