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

Model Number C20

Device Problem Protective Measures Problem (3015)

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

Event Date 04/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the anesthesia workstation generated alarms for high airway pressure.There is no information whether a patient was connected to the anesthesia workstation or not during the event.Manufacturer's ref #: (b)(4).

Manufacturer Narrative

The anesthesia workstation was investigated on site and the nozzle unit from the air gas module was replaced.The anesthesia workstation was successfully tested and returned to clinical use.The replaced nozzle unit was scrapped and could not be returned for investigation.The nozzle unit is a part of the gas module that regulate the inspiratory gas flow to the patient.An evaluation of the received logs confirm a flow increase from the air gas module leading to alarms for low fio2 and alarms for high airway pressure.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 unit contributed to the reported issue but without having been able to investigate the replaced part, 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: 8573097
• MDR Text Key: 143941652
• Report Number: 8010042-2019-00298
• 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: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• 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: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1