U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
AC-Powered Adjustable Hospital Bed - Product Code FNL
원인
Failure, mechanical: if the bed mechanism is cranked downward when the bed is already in its lowest position, the springs may cause the bed to rise suddenly if the bed is empty, more slowly if occupied by a patient, or when the patient exits the bed. for further information, please contact hill-rom, inc. at 800-445-3720.
조치
Consignees were notified of the problem by letter dated 11/11/08 and instructed to position the bed at least 3 inches above the lowest bed position in order to prevent the problem, and then to only use the pendant electronic controls to raise and lower the head and foot sections of the bed, until Hill-Rom can repair the bed. The letter was entitled "Urgent Medical Device Correction."
Hill-Rom 70 Semi-Electric Bed, Hill-Rom Company, Batesville, IN.; Model HS-968. The bed is a general purpose bed for use with low to medium acuity patients in the home care environment.