MAUDE Adverse Event Report: HILL-ROM BATESVILLE 80 EXTENDED CARE FULL-ELEC; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P3910B02

Device Problem Malposition of Device (2616)

Patient Problem Hip Fracture (2349)

Event Date 07/19/2021

Event Type  Injury  

Manufacturer Narrative

The hillrom technician found that the bed's support arms were damaged due to the transport bracket being left on the bed, not allowing the bed to lower properly and bending arms supports to lower.In addition at that time the customer declined repairs of the bed to be performed by hillrom.The customer wanted a new bed, stating the hillrom sales department at that time told her that she could get a discount from hillrom through spinlife, the customer did not move forward with this.The customer did have a third party outside of hillrom repair the bed frame.The customer also noted at this time to a hillrom representative that her son had fallen out of the bed many times because it was leaning to one side.She stated she had to take him to the hospital from the fall and that the doctor told her he had a broken hip, but it was an old injury from a past fall.It was asked if she told the hillrom technician about the fall when he was out to check the bed and she stated she did not.The hill-rom 80 bed is intended to be used to provide occupant support suited for household use and extended care environments.The users of this device are healthcare employees, non-clinical caregivers, and occupants who have the physical strength and cognitive skills to operate and control the product.The bed can accommodate a wide variety of prevention and treatment surfaces and the electric high/low elevation feature maximizes ease of use for caregivers.A search of the hillrom maintenance records did not show hillrom performed any preventative maintenance on this bed.The customer declined repairs of the bed to be performed by hillrom.From the information provided above and in accordance with the medical device reporting for manufacturers document, hillrom is erring on the side of caution and reporting this event due to the serious injury involved.Based on this information, no further action is required.

Event Description

Hillrom received a report from a customer stating the bed was tilting to one side.The bed was located at the account.The customer found her son with his legs hanging off the side of the bed and he complained of his waist hurting.She took him to several doctors and one determined his hip had a fracture.She stated the bone from this fracture became infected and he later had surgery.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: 80 EXTENDED CARE FULL-ELEC
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• 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: 12283303
• MDR Text Key: 265257990
• Report Number: 1824206-2021-00404
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: P3910B02
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2013
• 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
• Patient Outcome(s): Required Intervention