Recall Z-1220-2011 · FNL Bed, Ac-Powered Adjustable Hospital

Hill-Rom, Inc.

Hill-Rom TotalCare Bed, P1900, Hill-Rom, Batesville, IN. TheTotalCare Bed System is intended to porvide 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

Date	Feb 11, 2011 (initiated Feb 3, 2011)
Status	Terminated
Reason	The firm received one report that a patient was weighed on the bed at 53 Kg when the patient actually weighed 73 Kg. The patient expired the next day and it is inconclusive as to whether the scale was a contributing factor. The firm investigated and found that the software for the scale system did not clear the last patient weight from the history of the scale system.
Root cause	Software design
Action	The firm, Hill-Rom, sent a "URGENT MEDICAL DEVICE CORRECTION" letter dated January 19, 2011, along with a software upgrade (USB stick/flash drive) with instructions, to all affected customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to requests that facility service personnel immediately upgrade their software; complete and return the Customer Response Form via fax to 812-931-2410 or mail to: Hill-Rom Company, 1069 State Route 46 E, Batesville, IN 47006, Attn: MOD Coordinator J12 and forward a copy of this notice to an
Quantity	905 beds.
Distribution	Worldwide distribution: USA and countries including: AUSTRALIA, BRAZIL, CANADA, CHINA, EGYPT, GERMANY, GREECE, ITALY, JAPAN, KUWAIT, MALAYSIA, MEXICO, NETHERLANDS, OMAN, POLAND, QATAR, SAUDI ARABIA, SPAIN, SWEDEN, THAILAND, UNITED KINGDOM, VENEZUELA, and YEMEN.
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.