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

Model Number BREAS VIVO 50

Device Problems Break (1069); Noise, Audible (3273); Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2020

Event Type  malfunction  

Event Description

Incident description per the reporter: "vivisol (b)(4) received the following report (b)(6) 2020: the ventilator gave error 43 during active treatment (error in controlling the blower) and switched off by itself.After restart, the device gave a loud buzzing noise.The patient was not injured because his mother was present.The broken ventilator was fetched by vivisol (b)(4) and directly replaced by another vivo 50.

Event Description

Incident description per the reporter: "vivisol germany gmbh received the following report (b)(6) 2020: the ventilator gave error 43 during active treatment (error in controlling the blower) and switched off by itself.After restart, the device gave a loud buzzing noise.The patient was not injured because his mother was present.The broken ventilator was fetched by vivisol germany gmbh and directly replaced by another vivo 50.

• 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
• MDR Report Key: 11514581
• MDR Text Key: 246954247
• Report Number: 9617566-2020-00002
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00732182215005
• UDI-Public: 0732182215005
• Combination Product (y/n): N
• PMA/PMN Number: K123144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/08/2020

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: Health Professional
• Device Model Number: BREAS VIVO 50
• Device Catalogue Number: 215000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2020
• Initial Date Manufacturer Received: 04/08/2020
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 05/08/2020
• Supplement Dates FDA Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1