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

Model Number SERVO-S

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 12/30/2020

Event Type  malfunction  

Event Description

It was reported that the air gas module of the ventilator was contaminated with water.There was no patient harm.Manufacturer ref.#: (b)(4).

Event Description

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

Manufacturer Narrative

It was reported that the ventilators air gas module was contaminated with water and that internal leakage test failed.The service engineer found that the ventilators air gas module was defective and needed to be replaced.It was also reported that water had entered the ventilator from the hospital gas system.No part was returned for investigation.The evaluation of received device logs shows that the pre-use check internal leakage test failed with the reported message system volume too low as early as (b)(6) 2020, which will be used as the date of event.If the air gas module contains water, the patient may receive an amount of oxygen in the gas mixture that deviate from the expected.Flow and pressure may also deviate from the expected.Alarms will be activated if the failure occurs during ventilation.The most probable source of moisture/water into the air gas module is moist air from the hospital's external compressor, which in this case was confirmed in the service report.According to the user's manual, maximum levels of water (h2o < 7 g/m3) in the supplied gases to the ventilator must not be exceeded.

• Brand Name: SERVO-S
• 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: 11453139
• MDR Text Key: 238878603
• Report Number: 8010042-2021-00524
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K123149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SERVO-S
• Device Catalogue Number: 6640440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2015
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1