MAUDE Adverse Event Report: HILL-ROM, INC. TOTAL CARE BED; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number 1900

Device Problems Device Slipped (1584); Positioning Problem (3009)

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

Event Date 06/10/2014

Event Type  malfunction  

Event Description

The account reported that when placing the left head brake/steer pedal into brake, the right head brake steer pedal would still move, brakes are not holding.The bed was located c3 hallway at the account.There was no pt/user injury reported.(b)(4).

Manufacturer Narrative

Upon inspection, the technician found that the brake/steer torque tube was damaged causing the brake to move slightly.The technician did not state what caused the damage to the torque tube but it was mostly due to normal wear and tear.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2014.It is unk, if the facility performed any other preventative maintenance on this bed.The torque tube was replaced by the technician to resolve the issue.Based on this info, no further action is required.

• Brand Name: TOTAL CARE BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: jennifer morris ; 1069 state rt 46 e; batesville, IN 47006 ; 8129313121
• MDR Report Key: 4078317
• MDR Text Key: 4892844
• Report Number: 1824206-2014-01909
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K962942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/10/2014

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: Other
• Device Model Number: 1900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2014
• Initial Date FDA Received: 07/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2003
• 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