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 Death (1802)

Event Date 11/09/2020

Event Type  Death  

Manufacturer Narrative

In an abundance of caution, hillrom is reporting the patient death as the patient used a hillrom device prior to the events preceding his death.Hillrom contacted the patient's wife multiple times requesting the return of the device.At this time, the patient's wife has declined to return the device to hillrom for evaluation.As such, hillrom was unable to evaluate the device involved in this incident.The cause of death was determined to be anoxic brain injury and respiratory failure.Als is a progressive nervous system disease that affects nerve cells in the brain and spinal cord.Als is a fatal disease that often begins with muscle twitching and weakness in a limb, or slurred speech and eventually affects control of the muscles needed to move, speak, eat and breathe.The intended use of the volara device is for the mobilization of secretions.There were no indications of a malfunction as reported by the family.Based on the information provided, hillrom cannot rule out the device from causing or contributing to the reported death.No further information is available on this incident or device at this time.A follow up report will be sent if further information becomes available.

Event Description

Hillrom received a report from the patient's wife stating that the patient expired after using the volara device.The patients wife reported that the device 'loosened up all the junk in his throat and he (patient) couldn't get it out.' additionally, the patient's wife stated they did not have a suction device nor were they given anything.It was reported that on october 15th the patient's wife called 911 after the patient could not cough up secretions.Paramedics performed life saving measures and transported the patient to the hospital, were he was admitted to the icu and expired 7 days later.The device was at the patient's home at the time of the reported incident.This has been filed in our complaint handling system as (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: 10961599
• MDR Text Key: 220104077
• Report Number: 3008145987-2020-00003
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 56 YR