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 Known Impact Or Consequence To Patient (2692)

Event Date 03/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during patient treatment, noise from the anesthesia workstation was heard.The fio2 decreased and high pressure alarms were generated.There was no patient harm.(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).The anesthesia workstation was investigated on site and nozzle units from the fresh gas modules and the reflector gas module were replaced and returned for investigation.The nozzle units are a part of the gas modules that regulate the inspiratory gas flow to the patient.An evaluation of the logs confirm the reported event.The nozzle units were subjected to simulated use testing in a reference anesthesia workstation.The reported high pressure alarm was not reproduced, nor were any other alarms or faults found.Pm is performed every 5000 hours of operation or at least once a year.The nozzle units have a predetermined lifetime and is replaced at the extended pm every second year (24 months interval).It is possible that the replaced nozzle units contributed to the reported issue but without having been able to reproduce the reported issue, the true cause of the reported event cannot be determined.

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; roentgenvagen 2; solna
• MDR Report Key: 8478108
• MDR Text Key: 140887092
• Report Number: 8010042-2019-00233
• 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: 05/14/2019

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: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1