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

Model Number C20

Device Problems Decrease in Pressure (1490); Pressure Problem (3012)

Patient Problem No Patient Involvement (2645)

Event Date 07/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when the anesthesia workstation was connected to the wall gas supply it alarmed for air supply pressure low.There was no patient involvement.(b)(4).

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of maquet critical care ab (manufacturer).Ref.Exemption #: (b)(4).Getinge usa sales, llc (b)(4).Contact peron: (b)(6).Our field service engineer confirmed the fault during on-site investigation.The air gas module was found faulty and was replaced.The returned air gas module was simulated use tested in a reference anesthesia system.The system checkout performed initially failed on the gas supply test and the flow transducer test.The tests failed due to that the air gas module measured a lower air supply pressure than the actual wall supply pressure was.The allowed air supply pressure range is 2.5-6.5 bar.During test in ventilation mode, alarms for air supply pressure low were generated on and off.The ventilation mode test was ended after 2 days.Several system checkouts were performed after this and all tests passed without deviations.Evaluation of the received device logs confirm the reported alarms for air supply pressure low and the failing tests during system checkout.Our conclusion is that the air gas module was the cause of the reported failure.The root cause of the air gas module failure has not been determined since the failure is intermittent.

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
• MDR Report Key: 7740065
• MDR Text Key: 115905623
• Report Number: 8010042-2018-00395
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• 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
• Date Manufacturer Received: 07/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1