MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C30

Model Number C30

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 12/17/2014

Event Type  malfunction  

Event Description

It was reported that the suction module intermittently did not function.There was no patient 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.

• Brand Name: FLOW-I C30
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• Manufacturer Contact: magnus lindqvist ; rontgenvagen 2; solna S-171-54 ; SW S-17154 ; 7307705
• MDR Report Key: 4360609
• MDR Text Key: 18729657
• Report Number: 8010042-2014-00579
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/17/2014

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: C30
• Device Catalogue Number: 6677300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/17/2014
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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