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

Model Number 660P

Device Problems Pressure Problem (3012); Appropriate Term/Code Not Available (3191)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2015

Event Type  malfunction  

Event Description

The manufacturer received information alleging a power cord to a bi-level positive airway pressure (bipap) device had an exposed electrical contact.There was no report of patient harm or injury.The manufacturer has made multiple requests for the return of the device and ac power supply/power cord for evaluation.To date, no products have returned.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer has made multiple requests for the return of the device and ac power supply/power cord for evaluation.No product has been returned.The manufacturer is not able to confirm the allegation a power cord to a bi-level positive airway pressure (bipap) device had an exposed electrical contact.The user manual for this device cautions the user to periodically inspect electrical cords and cables for damage or signs of wear and to discontinue use and replace if damaged.There was no patient harm associated with this alleged event.The manufacturer concludes no further action is necessary.

• Brand Name: BIPAP PRO
• 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: 5353799
• MDR Text Key: 35727955
• Report Number: 2518422-2016-00082
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 660P
• Device Catalogue Number: 660P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2014
• 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