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

Model Number C20

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2017

Event Type  malfunction  

Event Description

It was reported that during the start of a case, while the patient was connected to the anesthesia system, the system shut-down.There was no patient harm.(b)(4).

Manufacturer Narrative

(b)(4).The company representative (fse) visited the hospital after the event but could not reproduce any problems.System check out passed and the anesthesia workstation was returned to service.The on/off switch, the monitoring pc board and the power control pc board were replaced by the fse as a preventative measure.The device logs were saved and sent in together with the replaced parts.The returned parts were investigated but the reported issues could not be reproduced.The received logs have no recordings indicating that there was a system shutdown from ventilation mode.All recorded system shutdowns occurred after the device had been set to standby mode and the case had been ended by the user as expected.We are unable to determine the true cause of the reported event.

Event Description

Manufacturer reference #: (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: 6485852
• MDR Text Key: 72793139
• Report Number: 8010042-2017-00165
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K133958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/14/2017

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?: Yes
• Initial Date Manufacturer Received: 03/20/2017
• Initial Date FDA Received: 04/12/2017
• Supplement Dates Manufacturer Received: 03/20/2017
• Supplement Dates FDA Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2016
• 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