MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP PRO; VENTILATOR, NON-CONTINOUS (RESPIRATOR)

Model Number 650P

Device Problems Contamination (1120); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problems Low Oxygen Saturation (2477); Respiratory Acidosis (2482)

Event Date 09/12/2015

Event Type  malfunction  

Event Description

It was alleged by an end user that he breathed in "smoke" while using a bi-level positive airway pressure (bipap) device.The end user reported being admitted to a hospital and treated with "breathing medications" and supplemental oxygen as a result of elevated carbon dioxide (paco2) and decreased oxygen (pao2) levels.The user was discharged after three days without further incident.The manufacturer received the device for evaluation.There was no evidence of thermal damage to any component.There was physical damage to the top enclosure, indicating a drop of the device.There was also evidence of dirt/dust contamination to the internal surfaces.The impeller assembly showed evidence of having cracked, likely due to the impeller becoming unbalanced from the build-up of contaminants.The failure of the blower assembly is a result of improper care of the device by the user and is not a result of a failure of the device during normal usage.The user reported that he had not received any replacement accessories such as filters "in about ten years".The user manual for this device instructs "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 "if you notice any unexplained changes in the performance of this device, if it is making unusual or harsh sounds, if it has been dropped or mishandled, if water is spilled into the enclosure, or if the enclosure is broken, disconnect the power cord and discontinue use.Contact your home care provider." the respironics bipap pro bi-flex system delivers positive airway pressure therapy for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing over (b)(6).It is for use in the home or hospital/institutional environment.Based on the information available, the manufacturer concludes the failure of the device was a result of user abuse/misuse, and that no further action is necessary.

• Brand Name: BIPAP PRO
• Type of Device: VENTILATOR, NON-CONTINOUS (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: 5124144
• MDR Text Key: 27359834
• Report Number: 2518422-2015-03046
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 650P
• Device Catalogue Number: 650P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2015
• Date Manufacturer Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2011
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 32 YR