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

Model Number SERVO-N

Device Problem Increase in Pressure (1491)

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

Event Date 04/05/2021

Event Type  malfunction  

Manufacturer Narrative

No service has been requested by the healthcare facility.No ventilator logs were provided and no parts have reportedly been replaced on the ventilator.Additional information regarding the used accessories in the patient circuit system stated that the healthcare facility are using an expiratory bacteria filter from another brand.It was reported that the ventilator had a set peep (positive end expiratory pressure) of 7 cm h2o but measured value of 14 cm h2o.Upon investigation by the healthcare facility, it was noted that the expiratory bacteria filter used between the patient circuit and expiratory side of the ventilator was found to have been saturated with condensed water from the patient circuit.When the expiratory bacteria filter was removed from the patient circuit, the ventilator measured correct peep as set.No further anomalies were found.The reported high peep along with information about a clogged expiratory bacteria filter indicate an increased expiratory resistance in the patient¿s breathing system.At high expiratory resistance, the patient does not have time to breathe properly during the expiratory phase before a new breath is initiated.This leads to that the peep value becomes higher than the preset.Alarms for high peep are then generated.The user¿s manual contains a warning that the expiratory airway pressure must be carefully monitored to protect the patient against accidently high airway pressure when using expiratory bacteria filters.Increased airway pressure could result from a clogged expiratory bacteria filter.The filter should be replaced if the expiratory resistance increases or after maximum 24 hours, whichever comes first.According to the healthcare facility, the expiratory bacteria filter was replaced every 24 hours but plans are now to replace it more frequently.The conclusion is that the described error was caused by a clogged expiratory bacteria filter and not a ventilator malfunction.

Event Description

It was reported that the ventilator measured a higher peep (positive end expiratory pressure) than set.There was no patient harm.Manufacturer's ref #: (b)(4).

• Brand Name: SERVO-N
• 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: 11744209
• MDR Text Key: 248784547
• Report Number: 8010042-2021-00964
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K180098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SERVO-N
• Device Catalogue Number: 6688600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/27/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1