MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C20

Model Number C20

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 11/27/2014

Event Type  malfunction  

Event Description

It was reported that technical alarms for an open safety valve during a non high airway pressure situation and airway pressure sensor error was generated.There was no pt connected to the anesthesia workstation at the time of the event.(b)(4).

Manufacturer Narrative

A supplemental medwatch report will be provided when the investigation is finished.

Manufacturer Narrative

The received device logs showed that the cause of the generated pressure sensor error and the safety valve issue was likely due to an intermittent incorrect offset value of the inspiratory pressure transducer in the anesthesia workstation.We have not received any defective parts nor any additional information to further investigate this issue despite several requests being made.

Event Description

(b)(4).

• Brand Name: FLOW-I C20
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• Manufacturer Contact: magnus lindqvist ; roentgenvagen 2 ; solna S-171-54 ; SW S-17154 ; 7307705
• MDR Report Key: 4353123
• MDR Text Key: 15108662
• Report Number: 8010042-2014-00577
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K133958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 11/27/2014

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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/27/2014
• Initial Date FDA Received: 12/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1