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

Model Number C20

Device Problem Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that during patient treatment, there was a loud bang heard from the anesthesia workstation.There was no patient harm.(b)(4).

Manufacturer Narrative

The anesthesia system was investigated by our distributor.No parts have been replaced or returned.The device logs were saved and sent for evaluation.Evaluation of the received device logs shows several alarms for airway pressure high and regulation pressure limited indicating a high pressure situation or that the user set upper pressure limit was incorrect set.The ventilation was switched between manual(man) and automatic (auto) ventilation several times and every time in auto ventilation the alarms indicating high pressure were generated.The auto ventilation was in pressure regulated volume control(prvc).In prvc the system delivers a pre-set tidal volume and the pressure is automatically regulated to deliver the pre-set volume but is limited to 5 cmh2o below the set upper pressure limit.The alarm regulation pressure limited is generated when the set tidal volume is not attained due to the imposed restriction of the set upper pressure limit.System checkout before and after the event passed without deviations and there is no technical alarms generated at the time for the event.When the upper pressure limit is reached and alarm is generated the safety valve open.The opening of the safety valve may be perceived as a knock/bang.There is no indication of a technical failure in the anesthesia system.The cause of the reported loud noise/bang has not been determined.

Event Description

Manufacturer 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: 7063364
• MDR Text Key: 93589261
• Report Number: 8010042-2017-00592
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K133958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

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?: No
• Initial Date Manufacturer Received: 11/13/2017
• Initial Date FDA Received: 11/28/2017
• Supplement Dates Manufacturer Received: 11/13/2017
• Supplement Dates FDA Received: 03/20/2018
• Date Device Manufactured: 12/04/2015
• 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