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Various Medical Devices Recalled by Respironics ( 2015-05-28)
- Starting date:
- May 28, 2015
- Posting date:
- July 9, 2015
- 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-54164
Recalled Product
- BIPAP AUTOSV
- BIPAP AUTOSV WITH SMARTCARD INT
- BIPAP AUTOSV WITH SMARTCARD INT, CORE PACKAGE
- BIPAP SYNCHRONY LAB SYSTEM
- BIPAP AUTOSV ADVANCED/ENCORE SMARTCARD
- BIPAP AUTOSV ADVANCED/ENCORE SMARTCARD/HEATED HUMIDIFIER
- OMNILAB ADVANCED, DOMESTIC
- OMNILAB ADVANCED, DOMESTIC CORE
- OMNILAB ADVANCED, CANADA
- OMNILAB ADVANCED, CANADA CORE
- BIPAP AUTOSV ADVANCED SYSTEM ONE
Reason
Philips has become aware that ResMed has issued an urgent field safety notice that described a statistically significant 2.5 percent absolute increased annual risk of cardiovascular mortality for those randomized to a ResMed Adaptive Servo Ventilation (ASV) Therapy compared to the control group. In the patient population with reduced Left Ventricular Ejection Fraction (LVEF = 45%), 10.0 percent of the ASV group experienced a cardiovascular death each year compared to 7.5 percent of the control group, representing a 33.5 percent relative increased risk of cardiovascular mortality (HR=1.335, 95%CI=(1.070, 1.666), P-value= 0.010).
Philips is actively evaluating the information provided by ResMed and examining if this might impact the medical care of patients who use the Philips devices listed above. Until Philips completes our investigation, based on the ResMed announcement, Philips is strongly recommending that clinicians adhere to the following recommendations:
Do not place new patients with symptomatic chronic heart failure (NYHA 2-4) and reduced LVEF=45%, and moderate to severe predominant central sleep apnea on ASV therapy. Before putting patients on ASV, each patient should be assessed for heart failure. in case of signs and symptoms of heart failure an objective assessment of LVEF should be performed. Current patients should be evaluated and a discussion about whether to discontinue ASV therapy should occur if a current patient is found to be in the at-risk population. If it is unknown whether a current patient falls within the at-risk population, the patient should be evaluated to determine if ASV therapy should continue.
Affected products
A.BIPAP AUTOSV
Lot or serial number
All
Model or catalog number
- 1008628
- CA1008628
Companies
- Manufacturer
-
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES
B.BIPAP AUTOSV WITH SMARTCARD INT
Lot or serial number
All
Model or catalog number
- 1038916
- 1044114
Companies
- Manufacturer
-
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES
C.BIPAP AUTOSV WITH SMARTCARD INT, CORE PACKAGE
Lot or serial number
All
Model or catalog number
- 1040718
- 1044235
Companies
- Manufacturer
-
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES
D.BIPAP SYNCHRONY LAB SYSTEM
Lot or serial number
All
Model or catalog number
- 1010771
Companies
- Manufacturer
-
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES
E.BIPAP AUTOSV ADVANCED/ENCORE SMARTCARD
Lot or serial number
All
Model or catalog number
- 1044288
Companies
- Manufacturer
-
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES
F.BIPAP AUTOSV ADVANCED/ENCORE SMARTCARD/HEATED HUMIDIFIER
Lot or serial number
All
Model or catalog number
- 1044289
Companies
- Manufacturer
-
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES
G.OMNILAB ADVANCED, DOMESTIC
Lot or serial number
All
Model or catalog number
- 1111122
Companies
- Manufacturer
-
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES
H.OMNILAB ADVANCED, DOMESTIC CORE
Lot or serial number
All
Model or catalog number
- 1043343
- 1111124
- Manufacturer
-
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES
Companies
I.OMNILAB ADVANCED, CANADA
Lot or serial number
All
Model or catalog number
- 1044278
Companies
- Manufacturer
-
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES
J.OMNILAB ADVANCED, CANADA CORE
Lot or serial number
All
Model or catalog number
- 1044280
Companies
- Manufacturer
-
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES
K.BIPAP AUTOSV ADVANCED SYSTEM ONE
Lot or serial number
All
Model or catalog number
- CA951HS
- CA951S
- CA961HS
- CA961NTS
- CA961S
- CA961TS
Companies
- Manufacturer
-
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES