MAUDE Adverse Event Report: HILL-ROM MANUFACTURING, INC. VOLARA; DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Model Number PVL1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Dyspnea (1816)

Event Type  Injury  

Event Description

Volara device utilized for airway clearance therapy on a patient mechanically ventilated on cardiac stepdown unit.Upon application of this device, patient with significant increased work of breathing and acute change in vital signs.This occurred on multiple occasions before device was pulled from use.

• Brand Name: VOLARA
• Type of Device: DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT
• Manufacturer (Section D): HILL-ROM MANUFACTURING, INC.
• MDR Report Key: 16324032
• MDR Text Key: 309203640
• Report Number: MW5114774
• Device Sequence Number: 1
• Product Code: NHJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVL1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 6 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White