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

Model Number P0819A

Device Problem Sparking (2595)

Patient Problem Insufficient Information (4580)

Event Date 10/10/2022

Event Type  malfunction  

Manufacturer Narrative

Hillrom became aware of a medwatch report of a power cord sparking and smelling like smoke on an envella bed.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.The user manual instructs that power cords require inspection routinely to ensure no damage has occurred during use.The manuals also include warnings such as incorrect use or handling may result in damage to the power cord.They also instruct that if damage has occurred remove immediately, and to properly remove the power cord from the electrical outlet during transfer or movement of the device.Physical damage of a cord would be readily noticeable to the user.The user would notice any integrity issues with the surrounding insulation (outer covering) when plugging or unplugging the device into the electrical outlet.If found to be damaged, the power cord and device would be immediately removed from the clinical environment.Specific information on the complainant and the device, including contact details, location and serial number, were not provided in the report received.Therefore, a thorough investigation of the event and the device could not be performed.Although there was no patient injury associated with the reported event, if a similar event were to recur, it could contribute to a serious injury or death.Therefore, hillrom considers this complaint a reportable event, if additional information on the complainant and/or the device will be received, the event will be re-assessed and categorized accordingly.Location of the device unknown.

Event Description

Hillrom became aware of a medwatch report of a power cord sparking and smelling like smoke on an envella bed.Information on the complainant and the device, including contact details, location and serial number, were not provided in the report received.This report was filed in our complaint handling system as (b)(4).

• 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: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 15672578
• MDR Text Key: 302591353
• Report Number: 1824206-2022-00470
• Device Sequence Number: 1
• Product Code: INX
• 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: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P0819A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2022
• 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