MAUDE Adverse Event Report: BREAS MEDICAL AB BREAS VIVO 50; RESPIRATORY THERAPY DEVICE (HOMECARE USE)

Model Number 215000

Device Problem Device Alarm System (1012)

Patient Problem No Information (3190)

Event Date 01/29/2019

Event Type  malfunction  

Event Description

Fault description per the reporter "error 42, internal battery will not be detected".Analysis of the device log files, however, showed that the correct error code associated with the event was error code #18.

• Brand Name: BREAS VIVO 50
• Type of Device: RESPIRATORY THERAPY DEVICE (HOMECARE USE)
• Manufacturer (Section D): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, 43533 ; SW 43533
• Manufacturer (Section G): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, 43533 ; SW 43533
• Manufacturer Contact: elisabeth carlsson ; foretagsvagen 1; molnlycke, 43533 ; SW 43533
• MDR Report Key: 8591501
• MDR Text Key: 144680707
• Report Number: 9617566-2019-00014
• Device Sequence Number: 1
• Product Code: NOU
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K123144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 215000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Date Manufacturer Received: 04/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1