|
Pediatric Care Bed Correction: KayserBetten Issues Correction for KayserBett IDA Beds
The FDA is aware that KayserBetten has issued a letter to affected customers recommending all KayserBett IDA pediatric care beds be corrected prior to continued use. Affected devices:
- Product Name: KayserBett IDA
KayserBetten stated that the KayserBett IDA model marketed in the U.S. has a similar risk of injury as a model sold outside the U.S. that was involved in a serious incident that resulted in the death of a child.
The User Manual instructs users to lock the adjustment function of the hand control with the provided key when the patient (child) is unattended. If the adjustment functions of the hand control are not locked with the provided key when the patient is unattended, there is an increased risk that the patient or other children will operate the hand control and trap themselves or others under the bed frame or between the bed frame and the floor. This can lead to serious injuries or death.
KayserBetten is replacing the hand control on all affected KayserBett IDA beds in the field in the U.S. with a modified hand control featuring an automatic locking function. The adjustment functions on the new hand control will lock automatically after each use. The hand control replacement will be performed by an authorized service technician at no cost to the customer. The U.S. distributor, Mobility Unlimited Inc. (KayserBetten US), will contact customers to schedule the replacement.
As of April 22, KayserBetten has reported no serious injuries or deaths associated with this issue.
This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact KayserBetten at luebben@kayserbetten.de.
|
