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:

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

A. Bellavista 1000

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

301.100.000

Companies
Manufacturer
IMTMEDICAL AG
GEWERBESTRASSE 8
BUCHS
SWITZERLAND

B. Bellavista 1000 (Neo)

Lot or serial number

160012

Model or catalog number

301.100.060

Companies
Manufacturer
IMTMEDICAL AG
GEWERBESTRASSE 8
BUCHS
SWITZERLAND

C. Bellavista 1000E

Lot or serial number

170031
170053
170166
170219
170243
170271
170280

Model or catalog number

301.100.100

Companies
Manufacturer
IMTMEDICAL AG
GEWERBESTRASSE 8
BUCHS
SWITZERLAND