Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiPAP), and Mechanical Ventilators (2021-06-14)

Starting date:
June 14, 2021
Posting date:
June 23, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-75887

Last updated:

Affected Products 

  1. BIPAP AUTOSV WITH SMARTCARD INT
  2. BIPAP AUTOSV WITH SMARTCARD INT, CORE PKG
  3. BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH SMARTCARD
  4. BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH SMARTCARD-CORE PACK
  5. TRILOGY 100 VENTILATOR, CANADA
  6. TRILOGY 100 VENTILATOR-INTERNATIONAL
  7. BIPAP AVAPS CORE PACKAGE, NORTH AMERICA
  8. BIPAP AUTOSV ADVANCED/ENCORE SMARTCARD
  9. BIPAP AUTOSV ADVANCED/ENCORE SMARTCARD/HEATED HUMIDIFIER
  10. TRILOGY 200, CANADA
  11. BIPAP A30 SYSTEM-VENTILATOR
  12. BIPAP A30 SYSTEM-VENTILATOR & SYSTEM ONE A-SERIES HEATED HUMIDIFIER
  13. BIPAP A40, CANADA
  14. BIPAP A40, CANADA, CORE PACKAGE

Reason

Philips has become aware of two (2) issues that may pose a risk for patients or users of Philips Respironics branded Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BIPAP), and Mechanical Ventilators:

  1. Philips has determined from user reports and testing that the Polyester-Based Polyurethane (PE-PUR) sound abatement foam used in Philips continuous and non-continuous ventilators may degrade under certain circumstances, and the degraded particles could potentially enter the air pathway of the device. This issue affects Philips Respironics branded CPAP’s, Bi-Levels, and Mechanical Ventilators.
     
  2. The results of testing performed by Philips indicate that the PE-PUR sound abatement foam used in these devices may emit certain chemicals. Our investigation to date indicates that this emission occurs during initial operation and may possibly continue throughout the device's useful life.

These issues impact all device product platforms manufactured with Polyester Polyurethane (PE-PUR) sound abatement foam.  There is no specific population of device serial numbers which are impacted.

Affected products

A. BIPAP AUTOSV WITH SMARTCARD INT

Lot or serial number

All lots.

Model or catalog number

1044114

Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

B. BIPAP AUTOSV WITH SMARTCARD INT, CORE PKG

Lot or serial number

All lots.

Model or catalog number

1044235

Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

C. BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH SMARTCARD

Lot or serial number

All lots.

Model or catalog number
  • 1029756
  • CA1029756
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

D. BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH SMARTCARD-CORE PACK

Lot or serial number

All lots.

Model or catalog number

CA1029759

Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

E. TRILOGY 100 VENTILATOR, CANADA

Lot or serial number

All lots.

Model or catalog number
  • CA1054096
  • CA1054096B
  • U1054260
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

F. TRILOGY 100 VENTILATOR-INTERNATIONAL

Lot or serial number

All lots.

Model or catalog number
  • 1054096
  • U1054096
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

G. BIPAP AVAPS CORE PACKAGE, NORTH AMERICA

Lot or serial number

All lots.

Model or catalog number

1029750

Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

H. BIPAP AUTOSV ADVANCED/ENCORE SMARTCARD

Lot or serial number

All lots.

Model or catalog number

1044288

Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

I. BIPAP AUTOSV ADVANCED/ENCORE SMARTCARD/HEATED HUMIDIFIER

Lot or serial number

All lots.

Model or catalog number

1044289

Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

J. TRILOGY 200, CANADA

Lot or serial number

All lots.

Model or catalog number
  • CA1032800
  • CA1032800B
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

K. BIPAP A30 SYSTEM-VENTILATOR

Lot or serial number

All lots.

Model or catalog number
  • 1076577
  • 1111147
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

L. BIPAP A30 SYSTEM-VENTILATOR & SYSTEM ONE A-SERIES HEATED HUMIDIFIER

Lot or serial number

All lots.

Model or catalog number
  • 1076578
  • 1111148
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

M. BIPAP A40, CANADA

Lot or serial number

All lots.

Model or catalog number
  • 1076579
  • 1111173
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

N. BIPAP A40, CANADA, CORE PACKAGE

Lot or serial number

All lots.

Model or catalog number

1111174

Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES