Field safety notice FSN-UK-2022-07

VR-7 side rail latch

Issued
Products
VR-7
Status
Closed
Last updated

Products affected

VR-7 beds manufactured between March 2021 and June 2022, serial numbers 7A21-0001 to 7B22-1184.

What has happened

Van Roon Medische Techniek has found that on some VR-7 beds made between March 2021 and June 2022, the latch of a side rail can come to rest in a position where it looks engaged but is not fully engaged. A rail in this state can be lowered by pressure from inside the bed.

The cause is a latch spring that is shorter than its drawing allows. Two reports of a rail lowering unexpectedly have been received from outside the UK. No patient injury has been reported.

Action to be taken by the user

  1. Until your beds have been corrected, check by hand that each raised side rail is locked: pull it gently towards you after raising it.
  2. Do not leave a patient at risk of falling with the side rails as their only protection.
  3. Your Van Roon engineer will contact you to arrange the correction, which takes about 40 minutes per bed and can be done with the patient in the bed.
  4. Return the acknowledgement form within 30 days.

Contact

For questions about this notice, contact the service desk on 0808 157 0614 (Monday to Friday, 08:00 to 17:30) or service@vanroon.uk, quoting FSN-UK-2022-07.

The competent authorities concerned have been told about this notice. This notice has been sent to every hospital on our records with the products affected.

Issued by Van Roon Medical UK Ltd on behalf of Van Roon Medische Techniek B.V., Leiden, on 14 November 2022.