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

Model Number C20

Device Problem Device Inoperable (1663)

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

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The facility performs their own service and repairs.No service has been requested.The device logs were received.Further information regarding the event was requested but no additional information has been given; no information about replaced parts or what the cause of the reported event was.Evaluation of the received device logs show that 3 cases were started on the given date of event.We have no information in which of the cases the reported event occurred.A patient circuit leakage test was successfully performed before first case was started.In between the first and second case a complete system checkout was successfully performed.The 1st case was ongoing for 13 minutes in both manual and automatic ventilation.Clinical alarms indicating a high pressure situation were generated during the automatic ventilation.The 2nd case was ongoing for 5 minutes in manual ventilation.No alarms generated.The 3rd case was ongoing for 47 minutes in automatic ventilation.No alarms were generated during the case.There are no technical error alarms on the given date of event.With this limited information the cause of the event cannot be determined.

Event Description

It was reported that the anesthesia workstation while connected to a patient failed ventilation intra-operative and that the manual ventilation didn¿t work either.Patient information was not provided.(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: 7421108
• MDR Text Key: 105393678
• Report Number: 8010042-2018-00182
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K160665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• 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
• Device Age: YR
• Date Manufacturer Received: 03/14/2018
• Date Device Manufactured: 12/19/2012
• 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