MAUDE Adverse Event Report: HILL-ROM BATESVILLE HR 1000,VB100/200; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number P1160B0000006

Device Problem Self-Activation or Keying (1557)

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

Event Date 03/16/2018

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the right hand side rail head down button was stuck needed to be replaced.It is necessary for the hill-rom 1000 bed to have an effective maintenance program.We recommend that you do annual preventive maintenance.Make sure that the controls are in good condition and that the membranes are not worn or torn.Do the ¿function checks¿.Make sure that the bed does not fail any of the function checks.Replace or repair parts as necessary.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.The technician replaced the right hand side rail down switch to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the bed functions would self run.The bed was located at the account.There was no patient/user injury reported.(b)(4).

• Brand Name: HR 1000,VB100/200
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 7384734
• MDR Text Key: 104044964
• Report Number: 1824206-2018-00135
• 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: company representative,consum
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/16/2018

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 Operator: Lay User/Patient
• Device Model Number: P1160B0000006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 03/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2016
• 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