MAUDE Adverse Event Report: HILL-ROM BATESVILLE P3200/P3201 VERSACARE BED; A/C POWERED ADJUSTABLE HOSPITAL

Model Number P3200K

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2017

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technical support representative advised the account to isolate the pendant and side rails to check for a stuck button.Per the hill-rom service manual, perform annual preventive maintenance procedures to make sure all versacare® bed components are functioning as originally designed.Make sure the head and intermediate side rails are not bent or twisted.Make sure the side rails lock correctly in the high position and you hear the latch click.Gently pull on each side rail to make sure it latched correctly.If the side rail is difficult to latch, make sure the latch components are clean and look for obstructions.Release each side rail from the up position, and let it fall freely.The side rail should lower slowly and smoothly.Remove the center arm cover, and examine the cable routing for pinching, binding, or damage.Make sure the latch mechanism of each side rail is in good condition.Remove the side rail cover, and make sure the mounting screws are fully installed.Make sure all functions on the caregiver control work correctly.Repair or replace the side rails as necessary.Per the hill-rom user manual: to install the pendant into the side rail 1.Position the pendant next to the opening in the intermediate side rail or head-end side rail, depending on the cable length.2.Insert the top edge of the pendant into the side rail so it engages the upper section of the side rail.3.Rotate the lower edge of the pendant in until it clicks into position inside the side rail.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.Three attempts have been made regarding a resolution to this contact line, with no response.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating when the bed is in ac or dc power, it automatically goes into chair mode.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as (b)(4).

• Brand Name: P3200/P3201 VERSACARE BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL
• 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: 6945602
• MDR Text Key: 90300810
• Report Number: 1824206-2017-00423
• 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: user facility
• Reporter Occupation: Hospital Service Technician
• Type of Report: Initial
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P3200K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2013
• 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