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

Model Number C20

Device Problem Improper Flow or Infusion (2954)

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

Event Date 05/03/2016

Event Type  malfunction  

Event Description

It was reported that during a surgery, when the oxygen concentration was set to 100 %, the anesthesia workstation only provided an oxygen concentration level of approximately 40 %.There was no report of patient harm reported.(b)(4).

Manufacturer Narrative

Company representatives visited the hospital and performed simulated use testing of the anesthesia workstation.The reported issue could not be reproduced on the concerned machine.The control printed circuit board was replaced preventative and the device logs were collected.The control printed circuit board was investigated but the reported issue could not be reproduced.The device log evaluation did not reveal anything to support the experienced event.During additional simulated use testing at the hospital on another unit, the reported issue was occasionally reproduced and the conclusions drawn from these tests are that the startup configuration chosen by the user is intermittently not retrieved by the system.This leads to a lower fio2 concentration in the fresh gas flow delivered to the patient.Alarms are generated to notify the user in such case.

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: 5653255
• MDR Text Key: 45140081
• Report Number: 8010042-2016-00259
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/04/2016
• Initial Date FDA Received: 05/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2015
• 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