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

Model Number FLOW-I C20

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 09/07/2019

Event Type  malfunction  

Event Description

It was reported that the anesthesia workstation failed the afgo leakage valve test during system check out.There was no patient connected to the anesthesia workstation during the event.Manufacturer´s ref #: (b)(4).

Event Description

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

Manufacturer Narrative

The company representative investigated the anesthesia workstation at the hospital and concluded that the afgo valve (additional fresh gas outlet valve) needed to be replaced.The replaced afgo valve was returned for investigation.The logs from the event was received and confirm the reported issue.The reported leakage could not be reproduced during component and simulated use testing.We have not been able to determine the true cause of the reported issue.

• Brand Name: FLOW-I
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 9096607
• MDR Text Key: 159517971
• Report Number: 8010042-2019-00692
• 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: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FLOW-I C20
• Device Catalogue Number: 6677200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1