MAUDE Adverse Event Report: BREAS MEDICAL AB BREAS; VIVO 30

Model Number VIVO 30

Device Problem No Flow (2991)

Patient Problem No Information (3190)

Event Date 01/01/2014

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

Distributor in (b)(4) reports a defective device does not deliver air.Defective blower returned to breas.

• Brand Name: BREAS
• Type of Device: VIVO 30
• Manufacturer (Section D): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, SE-43 5 33; SW SE-435 33
• Manufacturer (Section G): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, SE-43 5 33; SW SE-435 33
• Manufacturer Contact: ann-sofie svensson ; foretagsvagen 1; molnlycke, SE-43-5 33 ; SW SE-435 33 ; 631868800
• MDR Report Key: 5070156
• MDR Text Key: 25537420
• Report Number: 9617566-2015-00105
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K060546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Service Personnel
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: VIVO 30
• Device Catalogue Number: 202000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2013
• 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
• Patient Outcome(s): Other