MAUDE Adverse Event Report: HILL-ROM BATESVILLE 300 WOUND SURFACE; BED FLOTATION THERAPY POWERED

Model Number P4937EAS1

Device Problem Unintended Movement (3026)

Patient Problem Tissue Breakdown (2681)

Event Date 07/26/2017

Event Type  Injury  

Manufacturer Narrative

The hill-rom technician evaluated the bed and found the snaps on the center cushions had become unsnapped.The technician reconnected the snaps on the center cushions to resolve the issue.The patient is being treated with mupirocin ointment.The pressure sore is nearly healed and the patient will be seeing the wound care doctor again next week.Per the hill-rom service manual, during the initial inflation of mattress with bolster, the installer should adjust the bolsters into the proper location on the surface.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 had skin breakdown due to the bladders shifting inside the mattress.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).

• Brand Name: 300 WOUND SURFACE
• Type of Device: BED FLOTATION THERAPY POWERED
• 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: 6777202
• MDR Text Key: 82158463
• Report Number: 1824206-2017-00335
• Device Sequence Number: 1
• Product Code: IOQ
• 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,consum
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/26/2017

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: Other Caregivers
• Device Model Number: P4937EAS1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/26/2017
• Initial Date FDA Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2015
• 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
• Patient Age: 43 YR
• Patient Weight: 92