Field Corrective Action_ArjoHuntleigh Indigo (accessory to Enterprise series bed): Indigo power cord might wear during use which could lead to its damage and sparks emission.

 

Affected Medical Device : Indigo (accessory to Enterprise 5000X, Enterprise 8000X and Enterprise 9000X)

 

MDA Reference Number : MDA/FCA/2021-P091

 

MDA Registration Number : GMD26105408518A

 

Decription : Indigo power cord might wear during use which could lead to its damage and sparks emission.

 

Local Establishment Contact Detail :

Yi Hui
Regulatory Affair and Service Support
Best Contact (M) Sdn Bhd
13-12, Jalan Jalil Perkasa 13,Arked Esplanad, Bukit Jalil,57000 Kuala Lumpur.

Email : limyh@bestcontact.com.my

 A copy of FSN.