Device product
MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR107003LO
Z-1016-2026
Product summary
- Event
- Event 98185
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 15581 units
- Official record key
device-enforcement:Z-1016-2026
Official wording
Reason: Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/motor the hand pendant and pendant cords may overheat and, in rare instances, pose a risk of fire. Medline Industries, LP has received a total of (58) complaints associated with reports of pendant sparking, burning, melting, smoking or fire.
Code information: UDI/DI 40080196325901, All lots
Distribution pattern: US, CA, PA, GUAM, VI
Derived failure modes
-
Unknown
Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/motor the hand pendant and pendant cords may overheat and, in rare instances, pose a risk of fire. Medline Industries, LP has received a total of (58) complaints associated with reports of pendant sparking, burning, melting, smoking or fire.