MAUDE Adverse Event Report: HILL-ROM BATESVILLE ENVELLA BED; BED, AIR FLUIDIZED

Model Number P0819A

Device Problem Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2023

Event Type  malfunction  

Event Description

Hillrom received a report from a hillrom technician stating the bed was sparking.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The hillrom technician found the power cord needed to be replaced.The envella® air fluidized therapy system is intended for medical purposes to help treat or prevent pressure injuries, to treat severe or extensive burns, or to aid in circulation.This bed is an ideal support for patients who have advanced pressure injuries, flaps, grafts, or burns, and require frequent transfers or variable head elevation, and any other conditions appropriate for air fluidized therapy.The bed also can be used for intractable pain, extensive epidermal detachment, stevens-johnson syndrome, purpura fulminans, induce relaxation which may reduce need for sedative and pain medication, improve patient outcome, and reduce wound healing time.The bed permits easy positioning and egress, thereby enhancing the independence of patients.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in april 2022.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the external alarm to resolve the reported event.Based on this information, no further action is required.

• Brand Name: ENVELLA BED
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: brad wheeler ; 1069 state route 46 east; batesville, IN 47006 ; 3128199307
• MDR Report Key: 16147547
• MDR Text Key: 308726747
• Report Number: 1824206-2023-00027
• Device Sequence Number: 1
• Product Code: INX
• UDI-Device Identifier: 00887761013834
• UDI-Public: 010088776101383411191115
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P0819A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/09/2023
• Initial Date FDA Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2019
• 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