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

Model Number C20

Device Problems Leak/Splash (1354); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2016

Event Type  malfunction  

Event Description

It was reported that during patient treatment, when replacing the co2 absorber, the co2 absorber bypass valves were stuck in open position which resulted in a leakage.There was no patient harm.(b)(4).

Manufacturer Narrative

The anesthesia workstation was investigated on site by the biomedical engineer.One of the absorber bypass valves in the patient cassette was found open when it should have been closed.The bypass valve was replaced and the system was returned to clinical use after successful functional testing.An additional investigation performed by the biomedical engineer revealed that the spring inside the bypass valve had been stretched too much during cleaning.This led to a leakage since the co2 absorber bypass valve could not close properly when the absorber had been lowered (to replace co2 absorber).The absorber bypass valves are located in the patient cassette where the co2 absorber is docked, one at the inlet and one at the outlet.The main task of these valves is to lead the re-breathed patient gas through the co2 absorber in order to remove the co2 from the gas.This fault will not affect the system function while the absorber is docked in place.

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: 6621404
• MDR Text Key: 77312370
• Report Number: 8010042-2017-00255
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K133958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2017
• 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