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

Model Number C20

Device Problem Failure to Calibrate (2440)

Patient Problem No Patient Involvement (2645)

Event Date 05/29/2019

Event Type  malfunction  

Manufacturer Narrative

The anesthesia workstation was investigated on site by our field service engineer.The co2 absorber was leaking.The co2 absorber was replaced and it was reported that it was a visible damage on the co2 absorber.The co2 absorber was not returned for investigation.A photo of the faulty co2 absorber was received showing a crack in the bottom of the co2 absorber.Evaluation of the received device logs show that the internal test and pressure transducer test failed.The test failed due to possible leakage.Our conclusion is that the system checkout tests failed due to a physical damaged co2 absorber.How and when the co2 absorber got damaged has not been determined.(b)(4).

Event Description

It was reported that the anesthesia workstation failed the system check out.There was no patient involvement.Manufacturer reference # (b)(4).

• Brand Name: FLOW-I
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• 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: 8726257
• MDR Text Key: 148954679
• Report Number: 8010042-2019-00430
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K160665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2019
• Initial Date FDA Received: 06/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2013
• 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