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

Model Number C20

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2018

Event Type  malfunction  

Event Description

It was reported that inspiratory and expiratory valves in the patient cassette were stuck in closed position during patient treatment.There was no patient harm.(b)(4).

Manufacturer Narrative

The returned patient cassette including the allegedly stuck one way valves has been tested and there were no indications of stuck valves.The patient cassette functions as intended.According to the test log, a successful system check out (sco) was performed just prior to the event.There is no recorded sco after the event.Both the trend log and the internal log show that there were difficulties to ventilate the patient.There were alarms indicating a leakage.Based on the lack of technical alarms related to pressure and the lack of negative pressures recorded in the trend log, it is not likely that a stuck inspiratory and/or inspiratory valve contributed to the reported event.Based of the above information, we are unable to determine the root-cause of the reported problem.(b)(4).

Event Description

Manufacturer's 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: 7342876
• MDR Text Key: 102747683
• Report Number: 8010042-2018-00143
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K160665
• 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: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• 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
• Date Manufacturer Received: 03/09/2018
• Date Device Manufactured: 03/30/2017
• 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