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

Model Number C20

Device Problem Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that while in use on a patient, a noise was heard from the anesthesia workstation.The logs from the time of event also contain high pressure alarms.There was no patient harm.Manufacturer's ref #: (b)(4).

Event Description

Manufacturer's ref #:(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 person: (b)(6).The anesthesia workstation was investigated by the hospital biomedical engineer and the nozzle units in the gas modules were replaced.The nozzle units were disposed of by the customer.The nozzle unit is part of the gas module that regulates the inspiratory oxygen gas flow to the patient.The reported noise (vibration) may lead to deviation in the gas flow.An evaluation of the logs show that alarms for airway pressure high and fio2 low have been generated.System checkout performed prior to and after the event were successful.The reported event date was wrong and has been updated accordingly.The nozzle unit has 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 event but without investigating the replaced parts, the true cause of the reported event cannot be determined.

• Brand Name: FLOW-I C20
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• MDR Report Key: 8150459
• MDR Text Key: 130050612
• Report Number: 8010042-2018-00662
• 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: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• 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: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1