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:

• Model Numbers: BAB1000-01, BAB1000CON6102, BAB1007-01, BAB1101-01, BAB1102-01, BAB1103-01, BAB1107-01, BAB2000-01, BAB2101-01, BAB2102-01, BAB3000-01, BAB3101-01, BAB3107-01, BAB5000-01
• Spare Part Numbers: 8451622, 8546608, S8533571-031, S8533572-031, S8533570-031, S8542201-014, S8523559-031, 100806-03,100805-03
• Serial Number Range: P0512263 to P0551621
• Manufactured between November 2018 and June 2019].

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:

• It is recommended that the Safety Catches on the shower trolley Side Supports be inspected daily to ensure any of the catches are not broken.
• The patient is not left unattended at any time.
• The patient is fully assisted so that he/she does not grab, push or lean against the Side Supports during showering activities.
• Caregivers should limit pulling and pushing of the Side Supports with excessive force.
• Always adhere to the Safe Working Load as outlined in the IFU.

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