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

Model Number C20

Device Problem Tidal Volume Fluctuations (1634)

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

Event Date 02/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during patient treatment, the anesthesia workstation delivered a higher tidal volume than set.Alarm for high pressure in log.There was no patient harm reported.Manufacturer's ref #:(b)(4).

Event Description

Manufacturer's ref #:(b)(4).

Manufacturer Narrative

The anesthesia workstation (system) was examined by our field service engineer.No fault was found.The nozzle units in the gas modules were replaced as a precaution.The system was returned back for clinical use, no further issues have been reported.The returned nozzle units were simulated use tested in a reference system.A successful system checkout (sco) was performed and thereafter a ventilation test, with parameter settings as during the reported event, was performed during 2 days without any deviation in the performance noticed.The reported deviation between set and delivered volume, was not reproduced and no alarms for high pressure were generated.Evaluation of the system device logs show that the treatment was performed in a volume controlled mode with tidal volume set to 430 ml, respiratory rate set to 14 b/min and expiratory minute volume upper alarm limit set to 15 l/min.A few alarms for expiratory minute volume low, respiratory rate high, airway pressure high and leakage were generated during the treatment.No alarms for expiratory minute volume high were generated.The log shows that the last sco before the event passed and there is no technical error in the log to indicate a system malfunction.Our conclusion, even though no fault was reproduced during simulated use test, is that one of the nozzle units caused an oscillation in one of the gas modules.Oscillations may result in an extra flow delivered from the gas module.Alarms will be activated if the set alarm limits are exceeded.

• Brand Name: FLOW-I C20
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 8459898
• MDR Text Key: 140291928
• Report Number: 8010042-2019-00216
• 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: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• 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: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1