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 I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-75887
Last updated: 2021-08-06
Affected Products
- BIPAP AUTOSV WITH SMARTCARD INT
- BIPAP AUTOSV WITH SMARTCARD INT, CORE PKG
- BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH SMARTCARD
- BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH SMARTCARD-CORE PACK
- TRILOGY 100 VENTILATOR, CANADA
- TRILOGY 100 VENTILATOR-INTERNATIONAL
- BIPAP AVAPS CORE PACKAGE, NORTH AMERICA
- BIPAP AUTOSV ADVANCED/ENCORE SMARTCARD
- BIPAP AUTOSV ADVANCED/ENCORE SMARTCARD/HEATED HUMIDIFIER
- TRILOGY 200, CANADA
- BIPAP A30 SYSTEM-VENTILATOR
- BIPAP A30 SYSTEM-VENTILATOR & SYSTEM ONE A-SERIES HEATED HUMIDIFIER
- BIPAP A40, CANADA
- BIPAP A40, CANADA, CORE PACKAGE
Reason
Please view following link for related information.
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:
-
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.
- 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