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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Event Detail

Event ID 65259
Product Type Devices
Status Ongoing
Recalling Firm Hill-Rom, Inc.
City Batesville
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-30
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide distribution: USA (nationwide) and countries of: Canada, Columbia, Nigeria, Kuwait and Saudi Arabia.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress The TotalCare Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution. Bed model numbers: PAU001010784, PAU005010784, P1900, PAK169N10184, PAK169N10384, PA8171210184, PA8175210184, PA8175210384, PA8171210384, PA8171310384, and PA8173210384. The AccuMax Quantum VPC, Complete and Convertible mattresses are not serialized, but were distributed between September 2005 and April 2013 Class II Hill-Rom is initiating this recall due to a potential issue with TotalCare® Beds equipped with AccuMax Quantum" mattresses. If the bed is put into the chair egress position, the magnets on the mattress may not hold the bottom of the mattress flat to the bed frame. If this happens, the foot section of the mattress will extend away from the bed at about a 30° angle (as shown in the photo). A patient attempting to get back into the bed may assume that the mattress is against the bed and attempt to sit, but may miss the seat and sit on the foot section instead. This can result in the patient sliding down to the floor, with possible injury. If the patient falls, the result may be major critical muscular/skeletal injury. 4,121 Units Z-1794-2013