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

Model Number BREAS VIVO 50

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Death (1802)

Event Date 02/22/2019

Event Type  Death  

Event Description

According to hospital nurse: patient found by homecare provider in the morning.The patient circuit was not attached to the vivo 50.The police have taken possession of the device.The incident has most likely occured 21/2 or 22/2.

Event Description

According to hospital nurse: patient found by homecare provider in the morning.The patient curcuit was not attached to the vivo 50.The police have taken possession of the device.The incident has most likely occured (b)(6) 2021 or (b)(6) 2022.

• 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
• MDR Report Key: 8460625
• MDR Text Key: 140206385
• Report Number: 9617566-2019-00012
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2019

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?: Yes
• Device Operator: No Information
• Device Model Number: BREAS VIVO 50
• Device Catalogue Number: 215000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Initial Date Manufacturer Received: 02/22/2019
• Initial Date FDA Received: 03/28/2019
• Supplement Dates Manufacturer Received: 02/22/2019; 02/22/2019
• Supplement Dates FDA Received: 05/28/2019; 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death