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

Model Number SERVO-U

Device Problem Infusion or Flow Problem (2964)

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

Event Date 03/12/2021

Event Type  malfunction  

Event Description

It was reported that the ventilator failed flow transducer test during pre-use check.There was no patient involvement.Manufacturer's ref.#: (b)(4).

Event Description

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

Manufacturer Narrative

The ventilator was investigated on site and the o2 gas module was replaced and returned for further investigation.Simulated use test of the received o2 gas module has not reproduced the described customer issue with flow transducer failed during pre-use check.The review of the received device logs confirms the reported issue.The measured failed value in flow transducer test during pre-use check is just outside the accepted range.The failed pre-use check has been found mars 12, therefore the date of event was determined as (b)(6) 2021.If this fault happens during ventilation, 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 reported problem could not be reproduced, therefore the cause has not been established in this investigation.

• Brand Name: SERVO-U
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 11704845
• MDR Text Key: 246670673
• Report Number: 8010042-2021-00896
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• 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
• Date Manufacturer Received: 11/04/2021
• Patient Sequence Number: 1