Bellavista 1000, Bellavista 1000(Neo) & Bellavista 1000E (2019-10-30)

Starting date:

October 30, 2019

Posting date:

November 26, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71708

Last updated: 2019-11-26

• 
  Reason
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  Affected products

Affected Products

1. Bellavista 1000
2. Bellavista 1000 (Neo)
3. Bellavista 1000E

Reason

Bellavista 1000 ventilators hardware generations G2/3/4/5/6 can experience the following ""intermittent failures during ventilation"": lack of acoustic high priority alarm, presence of a 'no alarm' condition, presence of a 'fail safe state'.

• Lack of acoustic high priority alarm (continuous alarm tone) under specific conditions which may cause a delay in immediate action required to avert a life-threating situation.
• Presence of a 'no alarm' condition during a disconnect under specific use conditions which may cause a system leakage and potential for loss in ventilation therapy without activation of alarm.
• Presence of a 'fail safe state' under specific use conditions which may cause a device (ventilator) response by suspending ventilation to the patient.

Affected products