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

Model Number C20

Device Problem Reset Problem (3019)

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

Event Date 06/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that while on patient treatment, the anesthesia workstation shutdown, rebooted and ended up in standby mode.The hospital personnel restarted the ventilation and continued the patient treatment without further issues.Final patient outcome was reported to be no injury.(b)(4).

Manufacturer Narrative

The investigation into this matter consists of the received device logs and the information received initially.We have not, despite multiple attempts, been able to obtain additional information regarding the status of the concerned anesthesia workstation.Nor have we obtained information stating if any cause of the reported event could be identified or if any parts needed to be replaced.The received event log shows that four cases were started on the reported event date.In one of these cases, a shutdown without a preceding standby was logged.After the shutdown, the workstation restarted and ended up in standby, where after the case was restarted by the user and the continued for approximately 80 minutes before the case was ended and the system was set to standby in a normal way.There were no issues during the time in ventilation.The shutdown and restart are logged as normal shutdown and restart by the user.No technical alarms preceded the shutdown.Successful sco: s were performed prior to and after the event.Based on the received information and logs that does not lead to any clear conclusion, we are unable to determine the true cause of the reported event.(b)(4).Ref.Exemption #: e2018003.(b)(4).Contact person: (b)(6).

Event Description

Manufacturer's ref #: (b)(4).

• Brand Name: FLOW-I C20
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• MDR Report Key: 7671147
• MDR Text Key: 113644237
• Report Number: 8010042-2018-00344
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K160665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• 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
• Date Manufacturer Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1