MAUDE Adverse Event Report: BREAS MEDICAL AB VIVO50; VENTILATOR TROLLEY (TROLLEY STAND) (ACCESSORY)

Catalog Number	007384
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Ecchymosis (1818)
Date of Event	11/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is a voluntary report of non-serious adverse event.There was no visual damage of the ventilator.The defective trolley stand will be repaired or replaced.The problem has been reported to the supplier for further investigation.
Event or Problem Description
Note: voluntary report of non-serious adverse event.On (b)(6) 2021, breas was notified that a vivo 50 ventilator fell off a trolley stand onto patient's foot, causing a bruise which did not require medical intervention.The trolley stand for breas ventilator was missing a metal washer which rendered the mounting bracket for ventilator unstable.

• Brand Name: VIVO50
• Common Device Name: VENTILATOR TROLLEY (TROLLEY STAND) (ACCESSORY)
• 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: 12967503
• Report Number: 9617566-2021-00005
• Device Sequence Number: 19967006
• Product Code: CBK
• UDI-Device Identifier: 07321820073849
• UDI-Public: (01)07321820073849
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K123144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 12/09/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 007384
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MOUNTING PLATE (CATALOG# 007916); VIVO 50 VENTILATOR (CATALOG# 215116 S/N (B)(4))
• Patient Sex: Unknown