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

Model Number C20

Device Problems Leak/Splash (1354); Failure of Device to Self-Test (2937); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 06/28/2017

Event Type  malfunction  

Event Description

It was reported that there was noise and leakage from the afgo (additional fresh gas outlet) valve outlet.The system checkout failed in several sub-tests.There was no patient involvement.(b)(4).

Manufacturer Narrative

(b)(4).The company field service engineer investigated the anesthesia workstation at the hospital and concluded that the afgo valve (additional fresh gas outlet valve) needed to be replaced.The device logs were collected and were received together with the replaced afgo valve.The returned afgo valve was tested in a reference anesthesia workstation as well as in a test bench.The reported issues could not be reproduced.All tests passed and no unusual noise could be heard.The received logs confirms the reported failure of sub tests such as safety valve test and pressure transducer test which failed due to the target pressure not being reached in the system (possible leakage).We are not able to determine if the returned afgo valve contributed to, or caused the reported issues.

Event Description

(b)(4).

• Brand Name: FLOW-I C20
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• 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: 6731775
• MDR Text Key: 80807269
• Report Number: 8010042-2017-00337
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K133958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2017

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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: 06/28/2017
• Supplement Dates FDA Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2014
• 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