Notificaciones De Seguridad De Campo acerca de ArjoHuntleigh Passive Patient Lifts and Ceiling Lifts with four-point hanger bars intended for use with Passive Clip Slings and Clip Flite Slings

Field Safety Notice

SN2012(15)

2012-09-06

Ireland

HPRA

http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/arjohuntleigh-passive-patient-lifts-and-ceiling-lifts-with-four-point-hanger-bars-intended-for-use-with-passive-clip-slings-and-clip-flite-slings&id=887df825-9782-6eee-9b55-ff00008c97d0

Arjohuntleigh’s complaint trending has shown a number of events relating to clip detachments. analysis and investigation of the root cause of these reported events has shown that non-attachment or incorrect attachment of the clip has been a main cause of what has been perceived as detachments. if the sling clips are not applied or are not applied correctly, there is the potential for the patient to fall, resulting in injury to both the patient and/or the caregiver.  arjohuntleigh have been unsuccessful in their attempts to date to locate all devices in ireland affected by this field safety corrective action. this alert applies to any users of arjohuntleigh passive patient lifts and ceiling lifts on the irish market that have not previously carried out this recommended action.

The IMB advises that users:  1. Ensure the appropriate personnel are made aware of this notice.  2. Identify the location of all affected lifts.  3. If you / your institution have affected lifts, please follow the manufacturer’s recommendations as outlined in the attached field safety notice and ensure that the corrective action is completed on all affected medical devices.