MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SERVO GUARD; FILTER, BACTERIAL, BREATHING-CIRCUIT

Catalog Number 6595487

Device Problem Obstruction of Flow (2423)

Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)

Event Date 10/09/2019

Event Type  Injury  

Event Description

It was reported that during patient treatment, the ventilator stopped delivering volume.The patient experienced desaturation and bradycardia.A bacteria filter that was attached between the patient and the ventilator at the time of the event was found clogged.Final patient outcome was no injury.Manufacturer's ref #: (b)(4).

Manufacturer Narrative

The ventilator was investigated at site by our field service engineer.The reported event of the ventilator stopped delivering volume could be duplicated with the original patient circuit.A clogged expiratory bacteria filter was found at the expiratory inlet of the ventilator.After replacement, the ventilator passed all safety and functional tests and was cleared for clinical use.The ventilator logs were downloaded.Evaluation of received ventilator logs found that alarms for high peep (positive end expiratory pressure), high airway pressure and high continuous pressure were generated.The alarms along with information about a clogged expiratory bacteria filter indicate an increased expiratory resistance in the patient¿s breathing system.At high expiratory resistance, 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 is higher than the preset and can also cause that the pressure constantly is so high above peep that an alarm for high continuous pressure is 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.The user facility has been informed about the importance of changing the expiratory bacteria filters regularly as per manufacture recommendations.The conclusion is that the described error was caused by a clogged expiratory bacteria filter and not a ventilator malfunction.

Event Description

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

• Brand Name: SERVO GUARD
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 9225022
• MDR Text Key: 163934633
• Report Number: 3013876692-2019-00024
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6595487
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/27/2020
• Distributor Facility Aware Date: 01/27/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2020
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening