Page 2: Health Product InfoWatch – March 2018

New health product safety information

The following topics have been selected to raise awareness and, in some cases, to stimulate reporting of similar adverse reactions.

Case report

Recent Canadian or international cases are selected based on their seriousness, frequency of occurrence or the fact that the reactions are unexpected. Case Reports are considered suspicions and are presented to stimulate reporting of similar suspected adverse events.

Combined use of the EasyCare hospital bed and over-bed table - risk of patient entrapment

The safety of hospital beds has been closely monitored for over 20 years in Canada and several measures have been put in place to minimize the risk of patient entrapment.^{Footnote 1-6} Despite these efforts, patient entrapment with serious complications, including death, continues to be reported in Canada.

In August 2017, Health Canada received an incident report describing a patient death suspected of being associated with entrapment after the patient's neck was caught between a bed and an over-bed table. Investigation by the facility showed that certain over-bed tables ("C-shaped" base configuration) combined with the Joerns EasyCare bed create hazardous conditions in which the table can tip and become locked in place when the bed is lowered. If the bed is lowered while the base of the over-bed table is positioned underneath the bed in a specific alignment, the steel bars from the bed come into contact with the table's base, causing the table to tip (Figures 1 and 2). Once the table has tipped, the bed's steel bar continues to apply force to the table's base, making it difficult to bring the table to an upright position.

Final analysis of the incident by the manufacturer revealed that the bed functioned as intended and the root cause was identified as the table base causing an obstruction under the bed that was not cleared before lowering the bed. The user manual includes a warning regarding the importance of ensuring that the areas under and near the bed are free of people and obstructions before adjusting the bed.^{Footnote 7}

The facility's current approach to preventing this type of incident is to lock the patient's remote control of the bed when an over-bed table is in place above the bed.

Although Health Canada has not received any other similar complaints, it is acknowledged that the same risk may exist for other bed models depending on the bed and table configuration. As for any type of device, it is recommended to properly follow the Instructions for Use provided with the medical device.

Any case of bed entrapment or other serious or unexpected adverse incidents in patients using hospital beds or side rails should be reported to Health Canada using the Bed-related Entrapment and Fall Report Form, available on Health Canada's Web site.