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 Respiratory Failure (2484)

Event Date 09/05/2020

Event Type  Death  

Manufacturer Narrative

The volara device is intended to be used with patients over two years of age, 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.On december 8, 2020, during a 3-month follow-up call with the patient's mother, she reported that volara therapy has been so effective that the treatment schedule changed to bi-weekly.On december 17, 2020, 5:33 pm, the patient¿s mother, accompanied by the patient¿s hospice nurse contacted a hillrom respiratory technician for assistance with changing device settings due to the patient¿s pcp ordering an increase in pressure therapy to 20cm/h2o from the patient¿s previously used setting of 15cm/h2o due to the patient¿s declining health.The respiratory technician assisted the patient¿s nurse in changing the device settings per the new order, which was within the ordered range on file for this patient.At 6:27 pm the same day the patient¿s hospice nurse contacted the respiratory technician again and stated, after consulting with the patient¿s pcp she was advised to use the settings programmed in the device¿s preset 2-medium setting.The patient¿s hospice nurse was assisted by the respiratory technician in selecting the device¿s preset 2-medium setting.This patient¿s mother reported the patient¿s cause of death was determined to be due to the progression of his disease.However, the mother further stated she did not understand why the settings were incorrectly entered into the device than what was ordered by the patient's pcp.The request for return of the volara device was not successful therefore inspection of device functionality could not be completed.In addition, comparison of the treatment settings to the documented orders and assistance provided could not be confirmed on the device.A device malfunction could not be confirmed.Based on this information, no further action is required.

Event Description

Hillrom received a report from the customer on march 5, 2021.The patient¿s mother reported that incorrect settings were entered into the volara device.During a follow-up call on march 5, 2021, from the respiratory therapist with the patient¿s mother per volara procedure protocol, the patient¿s mother reported the patient died (b)(6) 2020.The patient¿s mother reported the patient¿s cause of death was respiratory failure due to his disease.Per a copy of the prescription form, the use of the device was ordered for off-label home ipv use for this patient by the patient's primary care provider (pcp).The device was located at the patients home.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: 11605563
• MDR Text Key: 243470047
• Report Number: 3008145987-2021-00002
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death
• Patient Age: 9 MO