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

Model Number C20

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the anesthesia workstation had a leakage in the system.There was no patient involvement.(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)(6).The anesthesia workstation was investigated by our company field service engineer (fse).The trouble shooting was ongoing when the hospital administration informed the fse that they did not want to continue with repairs and have declined any further repairs to this unit.The fse was unable to find the cause of the reported issue.The logs were downloaded and have been evaluated.The test log contains failing sub tests that are likely to have been caused by leakage.We have however not been able to determine the source of the leakage based by only the log evaluation.Based on the information above, we are not able to determine the true cause of the experienced event.

Event Description

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

• Brand Name: FLOW-I C20
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• MDR Report Key: 8248032
• MDR Text Key: 133212993
• Report Number: 8010042-2019-00027
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• 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: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1