MAUDE Adverse Event Report: BREAS VIVO 50; CONTINUOUS VENTILATOR

Model Number VIVO 50

Device Problems Volume Accuracy Problem (1675); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

Authorized distributor in (b)(4) reports a problem.Device has not sent to breas (b)(4) for investigation.The reported event happened after the firmware upgrade of the vivo 50 s/n (b)(4).The device before the upgrade worked properly, update was successful and setting was properly carried, during a ventilation test the technician found that the volume bar and flow are 0, the unit did not report any alarm and in the alarm log there is no evidence of fault.Based on the information received, the potential risk associated with the reported event is classified as serious since lost or unavailable parameters could lead to incorrect treatment.Based on the information provided at this time, including limited patient information, the event is considered reportable per 21 cfr part 803.3.

Manufacturer Narrative

Under (b)(4) law, patient information is considered confidential and will not be released by the hospital.Return of defective material to manufacturer for repair has been authorized (b)(4) but device has not yet been received.

• Brand Name: BREAS VIVO 50
• Type of Device: CONTINUOUS VENTILATOR
• Manufacturer Contact: maria johansson ; foretagsvagen 1; molnlycke SE-43-5 33 ; SW SE-435 33 ; 1868800
• MDR Report Key: 4653032
• MDR Text Key: 21176121
• Report Number: 9617566-2015-00014
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: 123144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: VIVO 50
• Device Catalogue Number: 215000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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
• Patient Outcome(s): Other