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

Model Number BREAS VIVO 50

Device Problems Overheating of Device (1437); Device Displays Incorrect Message (2591); Contamination /Decontamination Problem (2895); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/13/2019

Event Type  Death  

Manufacturer Narrative

A follow-up report will be submitted upon completion of this investigation.

Event Description

Incident description per the reporter: (b)(6) received the following report on august 27th, 2019: because of function failure 35, overtemperature alarm of vivo 50, the device terminated treatment after the alarm message and some time because the cooling air filter was dusty.The patient that was ventilated for 24 hours died, because his father went out of the house for some time and there was no other person that could solve the malfunction or change the device.

• 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: 11501927
• MDR Text Key: 240347107
• Report Number: 9617566-2019-00020
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00732182215005
• UDI-Public: 0732182215005
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BREAS VIVO 50
• Device Catalogue Number: 215000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1