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 Known Impact Or Consequence To Patient (2692)

Event Date 03/24/2017

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

(b)(4).The company field service engineer investigated the anesthesia workstation at the hospital and concluded that the inspiratory pressure transducer pc board needed to be replaced.The device logs and the replaced pc board were received for investigation.The received logs show that an inspiratory pressure transducer gain value slightly outside the allowed limit caused the pressure transducer test failure.Several system check outs in a reference machine was performed without being able to reproduce the reported pressure transducer test failure.During simulated use testing in ventilation mode, the measured peep value was lower than set regardless of peep setting.Microscopic inspection and electrical measurements of the returned pressure sensor did not reveal any deviations.No dirt or residues were found in the cavity holes of the pressure sensor that would explain the fault.A replacement of the pressure sensor on the received pressure transducer board (pc1781) solved the issue with a lower peep value than set.The cause of the experienced error was a defective pressure sensor on the inspiratory pressure transducer pc board.We have not been able to determine the root-cause to why the pressure sensor failed.

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: 6438827
• MDR Text Key: 71237880
• Report Number: 8010042-2017-00132
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K133958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• 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: 03/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2011
• 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