R40PED Powerchair 의 안전성 경고

Safety alert

2013-08-28

2013-08-28

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130828.html

Medical device safety alert: pride mobility r40ped powerchair the medicines and healthcare products regulatory agency (mhra), united kingdom has posted a medical device safety alert concerning r40ped powerchair manufactured by pride mobility products corporation. all the r40ped with mbl, ll-1000 power seat tilt actuator; manufactured from 26 april 2012 to 20 may 2013 are affected. the manufacturer has found that there is a potential for the stop bushing on the seating tilt actuator to fail. this may lead to a separation of the actuator’s internal components and the seat tilting backwards to a degree much greater than intended. furthermore, the end user may not have any means of detection for this failure mode prior to such an event. the manufacturer has received 2 consumer complaints on this issue. there is a potential that such a malfunction in the product can occur and could lead to serious personal injury and/or death. in order to alleviate any potential for this type of malfunction, the manufacturer will replace the affected actuator with a new assembly that has a more robust and proven stop bushing. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con306142 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 august 2013.