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

Model Number BREAS VIVO 50

Device Problems Use of Incorrect Control/Treatment Settings (1126); Incorrect, Inadequate or Imprecise Result or Readings (1535); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981); Pressure Problem (3012)

Patient Problem Death (1802)

Event Date 08/11/2016

Event Type  malfunction  

Event Description

During investigation, it was found that the device had been returned to breas distributor in the (b)(4) on 11 november 2016 by the healthcare provider for analysis, which was concluded on 24 november 2016.It showed that the ventilator had been used for a short period of 7 minutes, during which it had not been possible to stabilise the settings and have the device delivering the prescribed pressure to the patient.There were several short alarms but then a prolonged disconnection alarm to indicate a full disconnection of the circuit.There appears to have been a very short period towards the end of the session where events may have been stabilised but it was only temporary.The service software indicated that a calibration had been performed after the event on (b)(6) 2016.There is no evidence that settings were changed prior to or during the treatment period and although adjustments had been made to the device since that time, there was nothing other than the calibration, which may have affected the ventilator performance.It was also noted that the device failed the oxygen test due to a kinked tube: this would only have been relevant if oxygen was being entrained.During investigation, it was also found that the case was brought to investigation by the (b)(6) coroner office on 22 - 24 may 2018 ((b)(6) court of law).On 15 march 2019, breas obtained the coroner's conclusive verdict, which concludes that the "the use of the ventilator was not causative or contributory to [patient's name] death.[the patient] died of a very rare complication of an appropriate prophylactic medication that could not have been foreseen." this information is consistent with the initial notification in that the issue would be about administration of medications in conjunction with ventilation.Breas has reported this event only because breas device was referred to as a concomitant device to the event.

• 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: 8543884
• MDR Text Key: 151925569
• Report Number: 9617566-2019-00013
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 03/09/2019
• Initial Date FDA Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2012
• 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