MAUDE Adverse Event Report: BREAS MEDICAL AB BREAS VIVO 50; CONTINUOUS VENTILATOR, PRODUCT CODE: NOU,

Model Number VIVO 50

Device Problems Failure to Run on Battery (1466); Unexpected Shutdown (4019)

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

Event Date 01/11/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: fault tracing of the device could not establish any hardware or software failure with reference to the reported failure on the device.The described failure could not be duplicated in any matter and the failure could not be confirmed nor rejected due to the log file, for the time in question, had been erased prior to the arrival to breas medical gmbh.Conclusion and actions: no patient harm occurred as a result of the event.According to the reporter, the current risk mitigation worked as designed, giving an audible and visible alarm and a care giver was present to handle the situation.The risk mitigations in place are considered effective and would prevent any patient harm if the event to recur.We will continue to track and trend the issue according to the procedures in our quality management system.No further actions are planned at this time.This report is submitted retrospectively because the original report is not visible in maude database.

Event Description

Fault description per the reporter "the device has failed during ventilation when attaching the click-on battery (s/n (b)(4)).In that moment the device terminated treatment and shut down".This report is submitted retrospectively because the original report is not visible in maude database.

• Brand Name: BREAS VIVO 50
• Type of Device: CONTINUOUS VENTILATOR, PRODUCT CODE: NOU,
• 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: gabriel vasiliu ; foretagsvagen 1; molnlycke, 43533 ; SW 43533
• MDR Report Key: 14314952
• MDR Text Key: 294566800
• Report Number: 9617566-2018-00003
• 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: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/19/2018

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 Model Number: VIVO 50
• Device Catalogue Number: 215000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2016
• 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): Required Intervention