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

Model Number C30

Device Problems Leak/Splash (1354); Failure of Device to Self-Test (2937)

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

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the anesthesia system failed several sub tests during system checkout due to leakage.There was no patient involvement.(b)(4).

Manufacturer Narrative

The anesthesia system was investigated on-site by our field service engineer.The system checkout failed in several sub tests due to leakage.The leakage originated from the volume reflector.The system was tested with a new volume reflector and the system checkout passed.The original volume reflector was cleaned, installed in the system again and a new system checkout was performed that now passed without deviation.The volume reflector is a reservoir of exhaled gases.The purpose of the volume reflector is to store the patients expired gas so that the gas can be purified in the co2 absorber for partial re-use during next inspiration phase.The volume reflector is included in the routine cleaning procedure set up by the hospital and should be regular cleaned.The received device logs confirm the reported failure that the system checkout failed several sub tests due to leakage.Our conclusion is that the reported failure was caused by the volume reflector and that it was solved by cleaning the volume reflector.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).

Event Description

Manufacturer ref #:(b)(4).

• Brand Name: FLOW-I C30
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• MDR Report Key: 7398980
• MDR Text Key: 104690749
• Report Number: 8010042-2018-00170
• 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: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• 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?: No
• Date Manufacturer Received: 03/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1