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

Model Number 650P

Device Problems Device Reprocessing Problem (1091); Contamination (1120); Device Handling Problem (3265)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 01/18/2014

Event Type  malfunction  

Event Description

It was alleged by an end user that he inhaled "smoke" while using a bi-level positive airway pressure (bipap) device.The end user did not seek immediate medical attention, but reported being treated a day later in an emergency room for shortness of breath, nausea, hypertension, and confusion as a result of the alleged event.There was no serious or permanent injury reported.

Manufacturer Narrative

The manufacturer received the device for evaluation and was unable to confirm the complaint of "smoke" being emitted.There was evidence of dirt, dust, and tobacco contamination throughout the air path of the bipap which caused damage to the blower assembly.There was no evidence of thermal damage to any component.The device did not pass testing due to the damage to the blower assembly.The user manual provided with the device cautions the user, "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 failure of the device was a direct result of the environment it was used in, and lack of proper maintenance by the end user.No further action is necessary.

• Brand Name: BIPAP PRO
• Type of Device: VENTILATOR, NON-CONTINUOUS, RESPIRATOR
• Manufacturer (Section D): RESPIRONICS INC.; murrysville PA
• Manufacturer Contact: les edsall ; 1740 golden mile hwy.; monroeville, PA 15146 ; 7243877183
• MDR Report Key: 3770714
• MDR Text Key: 4372610
• Report Number: 2518422-2014-00148
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• 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?: Yes
• Date Returned to Manufacturer: 01/29/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2011
• 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
• Treatment: HEATED HUMIDIFIER, PN 1056215, SN (B)(4)
• Patient Outcome(s): Other