Urgent Medical Device Correction FA1210 : Puritan Bennett™ 980 Series Ventilator Reverse Polarity (C103 Capacitor)

 

Affected Medical Device : Puritan Bennett™ 980

 

MDA Reference Number : MDA/FCA/2021-P160

 

MDA Registration Number : GC95166567018

 

Decription :

This voluntary medical device correction is being taken following our investigation of six customer reports stating that a total of four ventilators became inoperable during use. Our investigation identified the root cause for these reports to be a manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly.

 

Local Establishment Contact Detail :

Mariani Binti Masjidan
Regulatory Affairs Specialist
Medtronic Malaysia Sdn Bhd
B-23-01, The Ascent, Paradigm | No.1, Jalan SS7/26A | 47301, Petaling Jaya, Selangor | Malaysia
Office 603.78838037

 

Email : mariani.binti.masjidan@medtronic.com

 

 A copy of FSN.