Corrective action reporting for FMI 32081 : Mounting issue for LullabyTMResus Plus/Prime dovetailmounts ontoLullabyTMWarmer side rails

 

 

Affected Medical Device : Datex-Ohmeda Lullaby Warmer

 

MDA Reference Number : MDA/FCA/2021-P134

 

MDA Registration Number : GC94331485917

 

Decription : GE Healthcare (GEHC) has become aware that the dovetail mount accessory used to mount the LullabyTMResus Plus/Prime device onto the side rails of the LullabyTMWarmer could potentially have a defect. This issue could cause the Resus device to fall when an external force is applied, potentially causing an injury to a caregiver or, in an extremely rare case, the patient.

 

Local Establishment Contact Detail :

Benedict Lee
ASEAN Regulatory Affairs Specialist
GE Healthcare Sdn Bhd
Level 6, 1 Sentral, Jln Travers, KL Sentral, 50470 KL
03 22739788

Email : [email protected]

 

 A copy of FSN.