FDA MedWatch - V60 Non-invasive Ventilator by Respironics: Class I Recall - Unexpected Device Shut Down

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Title: FDA MedWatch - V60 Non-invasive Ventilator by Respironics: Class I Recall - Unexpected Device Shut Down

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

V60 Non-invasive Ventilator by Respironics: Class I Recall - Unexpected Device Shut Down

AUDIENCE: Risk Manager, Nursing, Pulmonology, Critical Care Medicine

ISSUE: Respironics is recalling the V60 Non-invasive Ventilator because the pins within the internal cable that connects the ventilator's motor to the control board may become loose over time due to low frequency vibration. The loose pins may prevent data to be transferred between the motor and the control board, triggering the ventilator to shut down unexpectedly and to sound an alarm. An unexpected stop in ventilation therapy may cause serious adverse health consequences, including death.

• See the Recall Notice for a listing of affected serial numbers
• Manufacturing dates: April 2, 2009 to September 15, 2015
• Distribution dates: April 4, 2009 to September 14, 2015

BACKGROUND: The Respironics V60 Non-invasive Ventilator provides continuous or intermittent breathing support to pediatric patients weighing at least 44 pounds to adult patients. This ventilator is used in hospitals or other health care facilities under the direction of qualified medical professionals such as physicians, nurses, and respiratory therapists.

RECOMMENDATION: On May 8, 2017, Respironics California sent an "Urgent: Medical Device Recall" letter to its consumers. The letter provided the following information to customers:

• Appropriately trained personnel may continue using the V60. The incidence of failure is low.
• Ensure an alternative form of ventilation is available at all times, including intra-hospital transport (e.g. manual ventilation bag).
• Operate the ventilator as directed in the operator's manual including:
  • promptly attend all alarms presented by the ventilator;
  • use an external oxygen monitor, and to set the alarm thresholds appropriately;
  • ensure the correct circuits and masks identified in the operator's manual are being used;
• When possible, connect the ventilator to a remote call system.
• If the V60 shuts down, alarms, and displays any of the error codes 100A, 1006, 1007, 1008:
  • turn the V60 off
  • discontinue use of the V60
  • use an alternate ventilator
  • call your local customer service contact and report the failure by referencing FCO86600037A.

Health care professionals and consumers with questions about this device are instructed to contact Respironics California at 1-800-345-6443.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA recall notice, at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm559856.htm

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