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

Model Number	VIVO 50
Medical Device Problem Codes	Delayed Alarm (1011); Improper Alarm (2951)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2016
Additional Manufacturer Narrative
Under european law, patient information is considered confidential and will not be released by the hospital.
Event or Problem Description
Hospital in (b)(6) reports a problem encountered with a vivo 50 ventilator in a homecare environment, stating: "the alarm for [patient] disconnection does not always trigger as expected.During testing, a 40-second delay has been observed" [translated from (b)(6)].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, if physiological alarm settings are not properly used.Based on the information provided at this time, 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: 6050427
• Report Number: 9617566-2016-00003
• Device Sequence Number: 16384329
• Product Code: NOU
• UDI-Device Identifier: 07321822150005
• UDI-Public: 07321822150005
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K123144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Hospital Service Technician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2016

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: Lay User/Patient
• Device Model Number: VIVO 50
• Device Catalogue Number: 215000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2016
• Initial Report FDA Received Date: 10/24/2016
• 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