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

Model Number C20

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Date 05/21/2017

Event Type  malfunction  

Event Description

It was reported that the anesthesia workstation failed the pressure transducer test during system check out.There was no patient connected to the unit at the time.(b)(4).

Manufacturer Narrative

(b)(4).The anesthesia workstation was investigated on site by our field service engineer.The nozzle unit in the air gas module was replaced and the anesthesia workstation was returned to clinical use after successful function tests.The nozzle unit consists of a membrane, a mouthpiece and a feather spring.It is used for regulation of the gas flow through the gas module.The membrane in the nozzle unit is pressed against a mouthpiece with a feather spring to regulate the gas flow through the gas module.The received logs confirm the reported fault.The test log shows increased flow from the air gas module leading to increased pressure causing the pressure transducer test and the flow transducer test to fail.If the fault would occur during patient treatment, alarms such as airway pressure high and tidal/minute volume high are generated and a pressure relief via the fresh gas safety valve is done by the anesthesia system.The investigation of the replaced and returned nozzle unit could not reproduce the reported failing pressure transducer test.Several successful system check outs were performed.No visual defects explaining the reported event could be noticed.Based on the above information we are unable to determine the true cause of the reported event.

Event Description

Manufacturer's ref: (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: 6642866
• MDR Text Key: 77744919
• Report Number: 8010042-2017-00269
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K133958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• 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: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2016
• 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