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

Model Number C20

Device Problems Improper or Incorrect Procedure or Method (2017); Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2015

Event Type  malfunction  

Event Description

It was reported that when the user switched from simv (pc) + ps mode to prvc mode and having a leakage, the tidal volume from the prior mode was suggested to the user which unintentionally accepted the suggested tidal volume.The patient was therefore ventilated with a larger tidal volume than expected.There was no harm to the patient.(b)(4).

Manufacturer Narrative

(b)(4).The received device logs confirms that there was a leakage when the user switched from simv (pc) + ps mode to prvc mode and having a leakage, the tidal volume from the prior mode was suggested to the user which unintentially accepted the suggested tidal volume.Alarms for high pressure were generated when the set upper pressure limit was reached and the safety valve opened to release the pressure.There are no indications of any technical malfunctions in the received logs.Our conclusion is that the anesthesia workstation functioned as intended and that the acceptance of the suggested tidal volume by the user caused the experienced event.

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: 5124174
• MDR Text Key: 27678221
• Report Number: 8010042-2015-01018
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Followup
• Report Date: 09/24/2015

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2013
• 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