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

Model Number SERVO-I

Device Problem Obstruction of Flow (2423)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The device is manufactured by maquet critical care ab.Maquet medical systems is the importer of the device.A follow-up importer medical device report will be submitted once the results from the manufacturer are available.

Event Description

It was reported that while connected to the ventilator, the patient had elevated etco2 value.Once the expiratory bacterial filter was removed from the expiratory inlet of the ventilator, the value returned to normal.Patient's final outcome was no injury.Manufacturer's ref #: (b)(4).

Manufacturer Narrative

No service was requested.The ventilator was examined by the user facility and no malfunctions were found.There was no recurrence of the reported issue when the expiratory bacterial filter was removed.The ventilator was returned for clinical use.No filter was returned for investigation and no ventilator logs were provided.According to information from the user facility, the problem was caused by a clogged expiratory bacterial filter from another brand.This results in an increased expiratory resistance, where the patient does not have time to breathe properly during the expiratory phase before a new breath is initiated.The user¿s manual contains a warning that when filter is used, user should carefully monitor the airway pressure.A clogged filter could result in increased airway pressure.Replace the filter if the expiratory resistance increases or after maximum usage time according to filter specification, whichever comes first.Length of use for the subjected filter is unknown.The conclusion is that the described error was caused by a clogged expiratory bacterial filter and not a ventilator malfunction.4117.

Event Description

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

• Brand Name: SERVO-I
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 10074380
• MDR Text Key: 191711053
• Report Number: 3013876692-2020-00023
• Device Sequence Number: 1
• Product Code: CBK
• 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: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SERVO-I
• Device Catalogue Number: 6487800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2020
• Distributor Facility Aware Date: 09/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2020
• Date Manufacturer Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening