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

Model Number C20

Device Problem Gas/Air Leak (2946)

Patient Problem No Information (3190)

Event Date 08/24/2016

Event Type  malfunction  

Event Description

It was reported that during system check out, the anesthesia workstation failed the automatic leakage, the manual leakage, and the gas analyzer sub-tests.There was no patient connected to the anesthesia workstation at the time of the event.(b)(4).

Manufacturer Narrative

We have not received any information about how the reported issue was solved, and if any part(s) needed to be replaced, despite multiple attempts to obtain this information.The device logs were however, provided and an evaluation of the received logs confirmed the reported issue of a leakage sub-test failure and gas analyzer sub-test failure during the system check out tests.Without additional information, or the replaced part(s) to investigate, we are only able to conclude that the gas analyzer sub-test failed due to the reported leakage.The source of the leakage has however, not been determined from this investigation.

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: 5952692
• MDR Text Key: 55163760
• Report Number: 8010042-2016-00421
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: IZ
• PMA/PMN Number: K133958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• 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
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2012
• 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