MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR PRO C-FLEX+, SYSTEM ONE, 60 SERIES; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 460P

Device Problem Device Inoperable (1663)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/28/2016

Event Type  malfunction  

Event Description

The manufacturer was informed of an allegation by a patient's caregiver that the patient required admission to a hospital because her continuous positive airway pressure (cpap) device would not function.The patient was reportedly admitted for an unknown reason and discharged home two days later.No further information is available.The manufacturer received the cpap and associated heated humidifier for investigation.Both devices were heavily contaminated with tobacco and dirt/dust throughout.The cpap blower was damaged due to contamination, and the device did not function as a result.The philips respironics remstar pro c-flex+ system delivers positive airway pressure therapy for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing over 30kg ((b)(6) lbs.).It is for use in the home or hospital/institutional environment.This device is not intended for life support.The user manual associated with this device notes the following: "under normal usage, you should clean the gray foam filter at least once every two weeks and replace it with a new one every six months.The white ultra-fine filter is disposable and should be replaced after 30 nights of use or sooner if it appears dirty.Do not clean the ultra-fine filter.Caution: dirty inlet filters may cause high operating temperatures that may affect device performance.Regularly examine the inlet filters as needed for integrity and cleanliness.The user is also cautioned: "tobacco smoke may cause tar build-up within the device, which may result in the device malfunctioning." based on the information available, the manufacturer concludes the malfunction of the device is directly related to user abuse/misuse, and the failure is not a result of normal use and care.No further action is necessary.

• Brand Name: REMSTAR PRO C-FLEX+, SYSTEM ONE, 60 SERIES
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: wilfredo alvarez ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 5732112
• MDR Text Key: 47601323
• Report Number: 2518422-2016-02663
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 460P
• Device Catalogue Number: 460P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SYSTEM ONE HTD HUMID ASSY, SN (B)(4)
• Patient Outcome(s): Hospitalization
• Patient Age: 76 YR