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

Model Number M08594

Device Problem Gas/Air Leak (2946)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

Oxygen desaturation is a below-normal level of oxygen in your blood and can cause symptoms such as restlessness, confusion, shortness of breath, headaches or in serious cases can interfere with heart and brain function.Normal pulse oximeter readings range from 94 to 100 percent a value under 90 percent is considered low.Oxygen desaturation can be contributed to obstructed ventilation caused by mucus plugging of airways, endotracheal tube dislodgement and bronchospasm or pulmonary disorders such as asthma, atelectasis or pneumonia.Treatment typically consists of oxygen measurement (via blood test or pulse oximetry), oxygen administration and x-ray (in determining obstruction).A search of the hillrom maintenance records did not show hillrom performed any preventative maintenance on this device.The intended use of the volara device is for the mobilization of secretions.The patient¿s mother reported it¿s like it brought up to many secretion's and he (patient) couldn't tolerate it.The patients mother notified patient's hcp the following morning via email, volara therapy was discontinued and vest therapy was ordered.Patient's mother reported patient is tolerating vest therapy well.Based on the intended use of the device and the customer statement of brought up to many secretions it is likely that the device loosened an amount of secretions intolerable to the patient which could have contributed to the oxygen desaturation.Hillrom is conservatively reported this allegation as a serious injury.There was no alleged malfunction of the device.Based on this information, no further follow up is required.

Event Description

Hillrom received a report from the customer stating the patient had an acute oxygen desaturation as low as 69% during the three-minute volara therapy.Patient's mother reportedly had to keep going to the closet to get tubing pieces to help the device fit the trach due to hearing air leakage.Immediate medical attention was not sought as patient¿s mother stated she has been dealing with this for eight years, i know what to do in a situation like this.Patient's mother reported that patient's oxygen saturation continued to decrease throughout the day and into the night, dropping to 34%, unrelated to a volara therapy session.Patient recovered at home with supplemental oxygen administered by patient¿s mother for both desaturation events and the patients mother reported she ambued patient during the nighttime desaturation event.The device was located at the patient's home at the time of the events.This report was filed in our complaint handling system as complaint #(b)(4).

• 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: emily mitchell ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 10739551
• MDR Text Key: 213245835
• Report Number: 3008145987-2020-00002
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: M08594
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18 YR