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

Model Number SERVO-U

Device Problems Infusion or Flow Problem (2964); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 01/12/2021

Event Type  malfunction  

Event Description

It was reported that the ventilator was making noise and failed flow transducer test during pre-use check.There was no patient involvement.(b)(4).

Manufacturer Narrative

The ventilator was investigated at site by our field service engineer.The ventilator alarmed for low o2 concentration and failed flow transducer test during pre-use check.The ventilator was making noise.The investigation found defective o2 gas module.The problem was solved by replicating the o2 gas module.After replacement, the ventilator passed all functional, safety, and electrical tests to factory specification.The ventilator was cleared for clinical use and returned to customer.No device logs were received and the replaced o2 gas module was not returned for investigation, therefor the root cause for the reported problem could not be determined.

Event Description

Manufacture'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: sara soderholm roman ; roentgenvagen 2; solna
• MDR Report Key: 11300878
• MDR Text Key: 230948378
• Report Number: 8010042-2021-00305
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K180098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• 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?: No
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2020
• 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