Company: Hill Rom Inc.
Date of Enforcement Report 2/16/2011
Class ll:
PRODUCT
1) Hill-Rom TotalCare Bed, P1900. The TotalCare Bed System is intended to provide 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). Recall # Z-1220-2011;
2) Hill-Rom TotalCare Bariatric Bed, P1840. The TotalCare Bed System is intended to provide 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). Recall # Z-1221-2011.
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.
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letter dated January 19, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
945 units
DISTRIBUTION
Nationwide and Internationally
