Medical device manufacturer, ArjoHuntleigh Polska, has issued a medical device safety alert concerning its Concerto & Basic shower trolleys. The affected products are identified as follow:
The manufacturer is informing users of a safety-related corrective action that will be performed on the affected devices. Each Concerto & Basic shower trolley is equipped with two Side Supports, one on each side of the shower trolley. Each side support is secured by two Safety Catches which are used to fold down the supports as well as secure the support in the raised position.
According to the manufacturer, it has become aware that any of the 4 Safety Catch (es) may exhibit a mechanical failure (break in one of the arms of Safety Catch), which in certain circumstances may contribute to the Side Support unintentionally opening and may lead to a potential risk of patient fall, leading to possible injuries to patient and/or caregiver.
Until the day of the safety-related corrective action launch, the manufacturer has received six incidents with this failure mode where one out of four Safety Catches broke. Although the likelihood of an adverse injury or event is limited, the manufacturer is taking this matter very seriously and intends to perform corrective action on the affected units.
Affected users are advised to verify the condition of all 4 Safety Catches attached to their device. If they notice the break, they should withdraw the trolley from use. The device may stay in use until the upgrade is performed, providing that the following instructions are carefully followed:
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 14 August 2019