MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C30; GAS-MACHINE, ANESTHESIA

Model Number C30

Device Problem Leak/Splash (1354)

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

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

It was reported that the co2 absorber was leaking.The fault was detected in the automatic and manual ventilation leakage test during system checkout.There was no patient involvement.(b)(4).

Manufacturer Narrative

The anesthesia workstation was investigated on site by our distributor.The co2 absorber was replaced due to leakage.The visual inspection of the returned co2 absorber could not confirm any visual damage.Test of the returned co2 absorber installed in a reference system could not reproduce the reported leakage.System checkout passed without deviations; no leakage detected.No fault was reproduced with the returned co2 absorber.Evaluation of the received device logs confirms the reported leakage during system checkout and during leakage test.The measured leakage during the manual ventilation leakage test indicates that it was a large leakage.Evaluation of the device logs cannot verify if the leakage occurred before or after the co2 absorber was replaced.Our conclusion is that the leakage confirmed in the device logs was not caused by the returned co2 absorber.The cause of the reported leakage has not been determined.(b)(4).Ref.Exemption #: e2018003.(b)(4).

Event Description

(b)(4).

• Brand Name: FLOW-I C30
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• Manufacturer (Section G): MAGNUS LINDQVIST; maquet critical care ab; röntgenvägen 2, se-171 54; solna ; SW
• Manufacturer Contact: maquet critical care ab; röntgenvägen 2, se-171 54; solna
• MDR Report Key: 7681437
• MDR Text Key: 114020443
• Report Number: 8010042-2018-00352
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C30
• Device Catalogue Number: 6677300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1