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

Model Number C20

Device Problem Failure to Calibrate (2440)

Patient Problem No Patient Involvement (2645)

Event Date 04/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the anesthesia workstation failed the flow transducer test during system check out.There was no patient connected to the anesthesia workstation at the time of the event.Manufacturer's reference# (b)(4).

Manufacturer Narrative

The anesthesia workstation was investigated on-site by our field service engineer.The nozzle units in the gas modules were replaced and this solved the reported flow transducer test failure.No further issues have been reported after this.The nozzle units were not returned for investigation.Evaluation of the received device logs confirm the reported flow transducer test failure during system checkout.The flow measured by the expiratory flow transducer was out of range during these tests.The error message was ¿expiratory flow transducer flow out of range¿.The error message indicates that the measured expiratory flow transducer flow, is outside the interval 90 % to 110 % of the total flow from all gas modules.Our conclusion, based on that no further issues have been reported, is that the nozzle units were the cause of the failure.The true root cause of the failure has not been determined as no parts were returned.

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; roentgenvagen 2; solna
• MDR Report Key: 8640052
• MDR Text Key: 146057991
• Report Number: 8010042-2019-00348
• 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: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 05/24/2019
• Supplement Dates Manufacturer Received: 05/07/2019
• Supplement Dates FDA Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1