MAUDE Adverse Event Report: BREAS MEDICAL AB BREAS VIVO 50; CONTINUOUS VENTILATOR

Model Number	VIVO 50
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	10/01/2016
Event or Problem Description
Healthcare facility in the (b)(6) reports a problem encountered with a breas vivo 50 ventilator during treatment.Per the initial reporter: "the ventilator was discovered to have turned off for a period of 38 minutes.Staff had to physically turn the machine back on.The resident did not come to harm.Ventilator taken out of use and engineer contacted to check the machine.This was taken away by deva medical and checked.They completed all checks and they could find no fault with the machine.The history display shows that treatment was stopped at 18.16 and then restarted at 18.59.A full investigation has taken place and the outcome was that the machine has an intermittent fault, as it had done this at least once before.A deliberate act of turning off the ventilator has been ruled out." the reporter claims there was no patient injury as a result of the reported event, but if the situation were to recur, it might potentially result in serious injury.At this point, the initial reporter also concluded "intermittent fault could not be ruled out, neither could human intervention" after their contracted service partner deva could not find anything wrong with the device - the device passed all its tests.Based on the information provided at this time, including investigation results indicating a use error, the reported event is considered reportable per 21 cfr part 803.3.

• Brand Name: BREAS VIVO 50
• Common Device Name: CONTINUOUS VENTILATOR
• Manufacturer (Section D): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, SE-43 5 33; SW SE-435 33
• MDR Report Key: 6112205
• Report Number: 9617566-2016-00004
• Device Sequence Number: 16233976
• Product Code: NOU
• UDI-Device Identifier: 07321822150005
• UDI-Public: 07321822150005
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 11/18/2016

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
• Operator of Device: Nurse
• Device Model Number: VIVO 50
• Device Catalogue Number: 215000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2016
• Initial Report FDA Received Date: 11/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR