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

Model Number C20

Device Problems Device Displays Incorrect Message (2591); Noise, Audible (3273)

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

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

It was reported that while in use on a patient, there were sudden loud noises from the anesthesia workstation leading to opening of the fresh gas safety valve and alarms for high airway pressure.There was no patient harm reported.(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)(4).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 reported fault could be reproduced.Further investigations revealed that the cause of the reported issues was a faulty delta pressure sensor located inside the returned air gas module.Evaluation of the received device trend log, the event log and the test log confirm the reported issues.The air gas module delivered a higher flow than expected.This led to an increased level of air in the gas mix (and decreased level of o2).An increased flow from the air gas module also increased the pressure in the fresh gas line leading to the patient.Alarms such as airway pressure: high, fio2 low and rr: high were generated.The alarm airway pressure: high will lead to the activation of the fresh gas safety valve (opening) and will automatically force the system into its expiratory state, to avoid over-pressure situations.Our conclusion is that a delta pressure sensor in the air gas module was the cause of the reported failure.The root cause of the pressure sensor failure has not been determined.

Event Description

Manufacturer's reference#:(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: 7942988
• MDR Text Key: 123208470
• Report Number: 8010042-2018-00529
• 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: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• 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: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1