MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C20; GAS-MACHINE, ANESTHESIA

Model Number C20

Device Problems Sticking (1597); Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

At a visit to the hospital, it was reported that the expiratory one-way valve in the patient cassette was stuck in the closed position during the system check-out tests.There were no further details provided.There was no patient involvement reported.Manufacturer reference # : (b)(4).

Manufacturer Narrative

The hospital has not provided any further information about the event such as serial number of involved anesthesia workstation and the event date.All anesthesia workstations at the hospital including patient cassette with the inspiratory and the expiratory one-way valves were inspected by company representatives during a visit at the hospital.No faults were found during the inspection.The device logs have not been available for evaluation and it is therefore not possible to confirm the event although we cannot rule out the possibility that a stuck expiratory one way valve in the patient cassette may have occurred as reported.Prior investigations of similar failure modes have been performed in which different methods to simulate a stuck plate/disc have been used.The plate/disc was exposed to saline, human saliva and water which were added to and then extracted from a co2 absorber.When performing the simulation method above it was possible to reproduce the event with a stuck plate/disc but we do not have any evidence that these simulation methods correspond to what made the one-way valve to get stuck in closed position at the hospital.The root cause of a stuck plate/disc has not been possible to fully determine by the performed tests and analysis.

Event Description

(b)(4).

• Brand Name: FLOW-I C20
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• Manufacturer (Section G): MAGNUS LINDQVIST; maquet critical care ab; röntgenvägen 2, se-171 54; solna ; SW
• Manufacturer Contact: maquet critical care ab; röntgenvägen 2, se-171 54; solna
• MDR Report Key: 6325502
• MDR Text Key: 67491030
• Report Number: 8010042-2017-00058
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K133958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C20
• Device Catalogue Number: 6677200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1