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

Model Number P0819A

Device Problem Activation Problem (4042)

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

Event Date 11/27/2023

Event Type  malfunction  

Manufacturer Narrative

The envella bed is intended to help treat or prevent pressure injuries, treat severe or extensive burns, or aid in circulation.The bed¿s fluidization system, in the lower portion of the bed, is composed of microspheres (beads) put in motion by the bed¿s air system causing the beads to take on the properties of fluid that the patient¿s body can float in.Inspection of the bed noted that the cpr handle was damaged, and its function was not available on either side of the bed and was preventing the head of the bed from being lowered.When activated, the bed's cpr function lowers the head of the bed, turns off air fluidization and deflates the cushions to allow for a firm surface to perform cpr if needed.It is note that the head of the bed was able to be articulated into the flat position prior to the repair.The technician replaced the cpr handle and noted the bed functioned as designed following the repair.In this event, no harm occurred, as reported by the customer.The patient did not sustain permanent impairment of a body function or permanent damage to a body structure, discomfort an unpleasant sensation that typically stops once the stimulus is removed, is not life-threatening and does not require medical or surgical intervention to preclude permanent impairment of a body function or body structure, which concludes no serious injury occurred.Additionally, troubleshooting found ruled out a device malfunction.However, if the reported malfunction of inoperative cpr handle/function were to recur, it is likely to result in serious injury.

Event Description

It was reported that the head of the envella bed was not going down all the way, and the patient was uncomfortable.It was also reported that there was no harm with this event.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (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: estephania cardenas ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 18378050
• MDR Text Key: 331377473
• Report Number: 1824206-2023-01447
• Device Sequence Number: 1
• Product Code: INX
• UDI-Device Identifier: 00887761013834
• UDI-Public: 010088776101383411180221
• 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: 12/21/2023

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: 11/27/2023
• Initial Date FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2018
• 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