MAUDE Adverse Event Report: BREAS MEDICAL AB BREAS VIVO 40; RESPIRATORY THERAPY DEVICE (HOMECARE USE)

Model Number 201000

Device Problems Device Emits Odor (1425); Smoking (1585); Noise, Audible (3273)

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

Event Date 08/13/2019

Event Type  malfunction  

Event Description

Fault description per the reporter "at 10:37 pm during the titration phase in the sleep laboratory (during ongoing polysomnography) a bang occurred in the device with subsequent odor and smoke." the patient involved was not injured during the incident.

• Brand Name: BREAS VIVO 40
• 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: 11501347
• MDR Text Key: 242176553
• Report Number: 9617566-2019-00019
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00732182201000
• UDI-Public: 0732182201000
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K053607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 09/13/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 201000
• Device Catalogue Number: 201000
• Date Manufacturer Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2012
• 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