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

Model Number	M08594
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient initiated the use of vest, volara and nebulizers therapies after being discharged from the hospital in (b)(6) 2024 and was diagnosed with pectus deformity during an oncology appointment on (b)(6) 2024.The patient¿s mother stated that the cause of the pectus deformity is unknown, but suspects it is related to the use of the vest device as she experienced pain since she started using of the device on approximately 5/20/2024.The patient was consulted by her pulmonologist on (b)(6) 2024, who advised the family to hold the use of the devices.There was no report of device malfunction.The patient is a 4-year-old female with relevant history of b-cell acute lymphoblastic leukaemia (b-all) and prior to initiation of use of the devices, had been hospitalized for respiratory failure with hypoxemia and hypercapnia requiring high-frequency ventilation.During follow-up call with a baxter clinical support specialist on 9/12/2024, the patient's father stated that a physiotherapist will be consulted, and that the patient was using the vest device 'periodically'.The patient's father also stated he does not believe the use of volara device contributed to the pectus deformity; however, he believes the vest device could have been a contributing factor to the patient's condition 'due to the shake'.Multiple attempts to obtain additional information were performed by the baxter clinical support specialist, however, the patient's family was unresponsive to the latest follow-up attempts.This evaluation refers to the volara device involved in this event.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.Pectus deformity is a term for a chest wall deformity that is usually congenital.The deformity can be 1) familial (40% of cases), 2) associated with connective tissue disorders such as marfan¿s syndrome, 3) secondary to pulmonary conditions that produce increased inspiratory pressures over time, e.G., subglottic stenosis or laryngomalacia or 4) idiopathic (majority of cases).Age of onset is during infancy in 30-80% of cases, however, the age of onset is often different than the age at which it becomes a concern, e.G., adolescence, when the pectus deformity can progress to become deeper and more apparent.There are two main types of pectus deformity: pectus excavatum and pectus carinatum.Pectus excavatum is characterized by a sternum that caves in, causing a sunken appearance in the chest wall.Pectus carinatum is characterized by a breastbone that pushes outward, causing a protruding appearance in the chest wall.Both conditions can affect heart and lung function.Treatment options for pectus deformity (such as pectus excavatum) include wearing a brace to compress the chest, surgery to fix the deformity, physical therapy exercises to improve posture and chest expansion, mild cases may not require treatment.In this case, the patient was diagnosed with pectus deformity three months after the use of the vest and volara devices was initiated.The event was not life-threatening, and the patient will seek the assistance of a physiotherapist to treat the symptoms, however, since the pectus deformity has not fully resolved at this time, a serious injury due to permanent damage to a body structure cannot be excluded at present.Additionally, there was no report of malfunction of the devices.The exact cause of the reported event cannot be determined at this time; therefore, it cannot be excluded that the vest and/or volara devices contributed to the event.It was reported that the patient has resumed periodical use of the vest device, however, the patient¿s family was unresponsive to the latest follow-up attempts.If any additional and relevant information is received, the case will be re-assessed accordingly.
Event or Problem Description
It was reported that the patient initiated the use of vest, volara and nebulizers therapies after being discharged from the hospital in (b)(6) 2024 and was diagnosed with pectus deformity during an oncology appointment on (b)(6) 2024.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: VOLARA SYSTEM
• Common Device Name: DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT
• Manufacturer (Section D): HILL-ROM SINGAPORE; 1 yishun avenue 7; singapore, north east 76892 3; SN 768923
• Manufacturer Contact: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 20361894
• Report Number: 3008145987-2024-00029
• Device Sequence Number: 9574362
• Product Code: NHJ
• UDI-Device Identifier: 00887761984578
• UDI-Public: (01)00887761984578
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2024

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
• Device Model Number: M08594
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 4 YR
• Patient Sex: Female