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

Model Number C20

Device Problem Ventilation Problem in Device Environment (3027)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2017

Event Type  malfunction  

Event Description

It was reported that while using the anesthesia workstation for patient treatment, the staff found it difficult to ventilate the patient.The patient was disconnected from the anesthesia workstation and was ventilated manually.There was no patient harm.(b)(4).

Manufacturer Narrative

The hospital biomedical engineer investigated the anesthesia workstation at the hospital.No faults could be found.Several parts including expiratory and inspiratory one-way valves originating from the patient cassette were replaced as a preventive measure.The anesthesia workstation was successfully tested and was returned to clinical use.The investigation of the returned parts could not duplicate the reported behavior.The returned parts were not damaged and worked according to specification when tested in a reference anesthesia workstation i a laboratory environment.The received device logs show that the user switched ventilation modes between automatic ventilation and afgo mode several times during the surgery but we have not been able to confirm if the clinical alarms such as "end tidal co2: high and alarms for leakage, are related to that.We have not been able to determine the cause of the behavior.

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: 6913430
• MDR Text Key: 89514512
• Report Number: 8010042-2017-00481
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• 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?: Yes
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2015
• 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