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

Model Number C20

Device Problems Protective Measures Problem (3015); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during the inspiratory phase, a noise from the anesthesia workstation was heard and high pressure alarms were generated.There was no patient harm.(b)(4).

Manufacturer Narrative

We have not received any information whether any parts were replaced to solve the reported issue.The device logs were received and have been evaluated.The reported event with the generation of high pressure alarms can be verified in the logs.The logs indicate that there was an increased flow from the n2o gas module leading to alarms for low fio2 and high airway pressure.The high airway pressure will lead to activation (opening) of the fresh gas safety valve.This will automatically force the system into its expiratory state, avoiding over-pressure situations.Without receiving additional information about how the issue was solved and if any parts needed to be replaced, we have not been able to determine the cause of the increase in airway pressure.

Event Description

Manufacturer's ref #:1914mcc1466.

• Brand Name: FLOW-I C20
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 8478115
• MDR Text Key: 140903412
• Report Number: 8010042-2019-00234
• 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: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• 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: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1