MAUDE Adverse Event Report: BREAS MEDICAL AB BREAS VIVO 40; CINTIUOUS VENTILATOR

Model Number VIVO 40

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Information (3190)

Event Date 07/01/2014

Event Type  malfunction  

Manufacturer Narrative

This medwatch report is a result of a retrospective investigation of customer complaints and has been deemed reportable due to insufficient patient information.Based upon the information that breas presently possesses, it is unable to confirm whether the event is reportable under the standard set forth in the applicable fda regulations and guidance.Accordingly, in an abundance of caution, breas is filing a medwatch report for this event.Being part of a retrospective analysis, this report is submitted later than 30 days after the initial date on which breas became aware of the event, as has previously been discussed with the fda.

Event Description

Breas medical reports that the device displays volume and leakage as 0.

• Brand Name: BREAS VIVO 40
• Type of Device: CINTIUOUS VENTILATOR
• Manufacturer (Section D): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, SE-43 533; SW SE-43533
• Manufacturer (Section G): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, SE-43 533; SW SE-43533
• Manufacturer Contact: ann-sofie svensson ; foretagsvagen 1; molnlycke, SE-43-533 ; SW SE-43533 ; 631868800
• MDR Report Key: 5115820
• MDR Text Key: 27202419
• Report Number: 9617566-2015-00236
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K071702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service Personnel
• Remedial Action: Repair
• Report Date: 09/30/2015

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: No Information
• Device Model Number: VIVO 40
• Device Catalogue Number: 201000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2014
• 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