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

Model Number C20

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/12/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the anesthesia workstation failed to ventilate the patient.There was no patient harm reported.(b)(4).

Manufacturer Narrative

The anesthesia workstation was investigated on site by the hospital personnel, no service was requested.Additional information such as performed service intervention, defective or replaced part has been requested but not received.The device logs were received and show that two successful system check outs were performed on the date of the event.One system check out was performed before the event and one after the event when the system had been set to standby.The technical log has no recordings related to the event.There were a lot of switches between ventilation modes such as man, prvc, and pressure support during the recorded ventilation period.The internal log contains clinical alarms such as respiratory rate: high, regulation pressure limited and airway pressure: high and the issues seem to have been started after the system had been switched to prvc.The trend log shows that the ppeak pressure and respiratory rate had variations on different occasions during the period.We have not been able to fully determine why these variations occurred but in combination with the generated alarms regulation pressure limited, airway pressure: high and respiratory rate: high it may be an indication of a blockage (most likely in the breathing circuit)but we have not been able to determine the source or location of the possible blockage.(b)(4).Ref.Exemption #: e2018003.(b)(4).

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: 7514278
• MDR Text Key: 108355573
• Report Number: 8010042-2018-00232
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• 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?: No
• Date Manufacturer Received: 04/17/2018
• Date Device Manufactured: 03/24/2015
• 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