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

Model Number C30

Device Problem Protective Measures Problem (3015)

Patient Problem No Patient Involvement (2645)

Event Date 12/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during system check out, the automatic ventilation leakage test and the additional fresh gas outlet valve (afgo) leakage test failed.There was no patient connected to the anesthesia workstation at the time of the event.(b)(4).

Manufacturer Narrative

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 peron: (b)(4).The replaced afgo valve has been returned for investigation.The logs from the event was received and confirm the reported issue.The reported leakage could be reproduced during component and simulated use testing.The cause of the reported afgo leakage test failure was an o-ring/seal inside the afgo valve not being able to seal properly.During the annual preventive maintenance (pm), an extra test of the afgo valve is performed.No parts are replaced in the afgo valve during pm.

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: 8256473
• MDR Text Key: 133485331
• Report Number: 8010042-2019-00035
• 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: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• 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: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1