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

Model Number M08594

Device Problem Inadequate or Insufficient Training (1643)

Patient Problem Insufficient Information (4580)

Event Date 08/05/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that with use of the volara for home therapy the patient was unable to comprehend how to work the device and went to the icu.It is noted the patient is a 20-year-old female, spanish speaking and has a relevant medical history of cerebral palsy.The patient¿s physician requested a bilingual respiratory trainer for the patient.Respiratory dictation shows the device circuit was used through its 90 count and needed to be changed.The patient¿s mother did not realize this needed to occur and thought the device was broken, therefore therapy was not delivered to the patient for a period of time.No call was made by the customer on this event, however the patient¿s physician reached out to hillrom for awareness.At some point the patient went to the icu, however no dates or reason for admission to the icu was provided.From the physician¿s letter to hillrom, there is suggestion that the patient¿s admission to the hospital may have been related to the patient not receiving the therapy on the device.Of note, respiratory has documentation that the patient/family has not responded to any of the follow up calls or letters sent by the clinical support team to follow-up on therapy use.It is documented that resolution occurred with the respiratory trainer going to the home, re-educating the patient/family, changed language on the device to spanish and documentation shows this went well with no additional issues.There was no alleged malfunction, and the device is staying with the patient.Follow-up attempts were made with the customer; however, they have not provided any further details of the initial alleged harm/injury associated with the device, including confirmation on if the inability to use the device contributing to the patient¿s icu admission, injury, date of injury, medical intervention provided, admitting diagnosis, patient¿s outcome, and delay.Hillrom has received no information back on the above.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 oxygen supply.There was no malfunction reported, however based on potential user error of the customer not having awareness that the device circuit needed to be changed and thinking the device was broken, the inability to use the device cannot be excluded from causing or contributing to the patient¿s admission to the icu, therefore hillorm/baxter is cautiously reporting this event.Based on this information, no further action is required.

Event Description

It was reported that with use of the volara for home therapy the patient was unable to comprehend how to work the device and went to the icu.It is noted the patient is a 20-year-old female, spanish speaking and has a relevant medical history of cerebral palsy.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
• Manufacturer Contact: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 15327979
• MDR Text Key: 298980305
• Report Number: 3008145987-2022-00012
• 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: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• 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
• Date Manufacturer Received: 08/10/2022
• 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: 20 YR
• Patient Sex: Female