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

Model Number 960T

Device Problems Thermal Decomposition of Device (1071); Use of Device Problem (1670)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2016

Event Type  malfunction  

Event Description

A durable medical equipment supplier(dme) alleged that a power cord had experienced a thermal event when used with a bilevel positive airway pressure (bipap) device.The manufacturer has requested the return of the devices for evaluation.To date, no product has been returned.A follow up report will be filed upon completion of the manufacturer's investigation.There was no report of patient harm or injury.

Manufacturer Narrative

The manufacturer's investigation inspected the returned device and observed evidence of thermal deformation to the external surface of the dc power supply enclosure.This was a result of the enclosure being exposed to an unknown external heat source and is not related to the operation of the device.Product labeling warns the user to periodically inspect electrical cords and cables for damage or signs of wear and to discontinue use and replace if damaged.The power cord meets all relative ul and iec standards.The manufacturer concludes the reported event was the result of owner misuse or abuse.Based on the available information, the manufacturer concludes no further action is necessary.

• Brand Name: BIPAP AUTOSV
• Type of Device: VENTILATOR,NON-CONTINUOUS RESPIRATOR
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge lane; murrysville 15668
• Manufacturer (Section G): RESPIRONICS, INC; 1001 murry ridge lane; murrysville 15668
• Manufacturer Contact: wilfredo alvarez ; 312 alvin drive; new kensington 15068 ; 7243349303
• MDR Report Key: 5463332
• MDR Text Key: 39465921
• Report Number: 2518422-2016-00694
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 960T
• Device Catalogue Number: 960T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2016
• Initial Date FDA Received: 02/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2015
• 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 Age: 59 YR