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

Model Number P0819A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 02/28/2018

Event Type  Injury  

Manufacturer Narrative

The hill-rom technician found the staff had failed to restart the air fluidized therapy.The technician found no problem for this device.The patient's sacral wound progressed from a deep tissue injury to a stage 4.The patient was treated with low frequency ultrasounds and advanced wound care products.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the patient's sacrum wound worsened to a stage 4.The bed was located at the account.There was a patient/user injury reported.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: erin padgett ; 1069 state route 46 east; batesville, IN 47006 ; 8129312791
• MDR Report Key: 7349537
• MDR Text Key: 102771248
• Report Number: 1824206-2018-00119
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: P0819A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1