MAUDE Adverse Event Report: HILL-ROM SINGAPORE VOLARA, HC,NA; DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Model Number M08594

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

Patient Problem Hemoptysis (1887)

Event Date 12/01/2022

Event Type  Injury  

Event Description

It was initially reported by the patient that he received an error code 014 excessive therapy pressure on the volara device.The patient also reported a historical event of bloody sputum that required hospitalization.This event was captured under hillrom complaint ref # (b)(4).

Manufacturer Narrative

The patient is a 70-year-old male with a medical history of bronchiectasis, persistent right hemidiaphragm elevation, and atelectasis.The patient was trained and initiated therapy with the volara device on (b)(6) 2021.The hillrom respiratory clinician addressed the reported error code 014 and reviewed correct set up of the device, but the patient was not near the device.The patient stated he believed the goal was to get the pressure high with exhalation and to ¿breath out hard to get a higher number¿ as he does when he is in the doctor¿s office for testing and is using the high preset.The patient stated he had been blowing hard to get the pressure to reach 60's and 70¿s.The hillrom respiratory clinician reviewed pressure, therapy mechanism of action, and breath instruction.The patient then recalled he was taught to breathe normally.The patient initially denied a trainer visit stating he understood the breathing technique and would retry.The hillrom respiratory clinician reviewed pressure and normal breathing again and reminded the patient the device is equipped with alarms for notification of conditions that require attention by the user.The patient was advised to speak with his healthcare team.The patient then self-reported a long history of blood in the sputum/lungs even prior to volara use and doctors have been unable to determine the cause.A diagnostic bronchoscopy was performed on an unknown date in 2021 and did not yield a diagnosis.Prior to volara therapy, the patient reported he was using the vest system.During a hospitalization on an unreported date, the patient tried the volara device while in the hospital and liked it so much the doctor discontinued the vest and prescribed volara.The patient reported another occurrence of bloody sputum/possible lung bleeding on approximately (b)(6) 2022, which the patient was hospitalized for.An x-ray was performed, and the patient was discharged.Nothing was found and the bloody sputum resolved.The patient stated he did not know if the cause was due to the volara device and incorrect breathing technique.The patient has no active bleeding currently and has been using the volara device since the hospitalization without incident.The hillrom respiratory clinician reviewed relative contraindications/adverse conditions with the patient and will schedule a trainer visit to review the device and observe the patient completing therapy.The volara system is intended for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and has the ability to provide supplemental oxygen when used with an oxygen supply.The device instructions for use (ifu) state on-screen caution messages let you know that an issue has occurred.Follow the on-screen instructions to troubleshoot the issue.Solutions for error code 014 state make sure the correct patient circuit is set up for the required therapy.For details, see assemble and connect the patient circuit¿ on page 17 (of the device ifu).Press return after you read the on-screen message.In this event, for the initial complaint of error code 014, the device functioned as designed and provided an error code message alerting the patient to ensure the correct patient circuit is set up.In assessing the historical discussion, bloody sputum, or hemoptysis, is defined as coughing up blood derived from the lungs or bronchial tubes.In this event, the patient experienced an event of bloody sputum concurrent with use of the volara device and required medical intervention (hospitalization) to preclude permanent impairment of a body function or permanent damage to a body structure, concluding a serious injury (si) occurred.There is no indication the report of bloody sputum/possible lung bleeding was life threatening, and the patient stated he has a history of blood sputum with no known cause prior to use of the volara device.The cause of the bloody sputum (si) is unknown, however, likely multifactorial due to his relevant history of bloody sputum prior to use of the device, pulmonary disease pathology, and possibly his reported incorrect breathing technique (use error) while using the device.Therefore, it is unable to be determined at this time if the device contributed to the si.If additional information is obtained, the complaint will be updated accordingly.

• Brand Name: VOLARA, HC,NA
• Type of Device: DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT
• Manufacturer (Section D): HILL-ROM SINGAPORE; 1 yishun avenue 7; singapore, north east 76892 3; SN 768923
• Manufacturer Contact: frances coote ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 16903495
• MDR Text Key: 314921117
• Report Number: 3008145987-2023-00006
• Device Sequence Number: 1
• Product Code: NHJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: M08594
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male