MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR AUTO M SERIES AFLEX; VENTILATOR, NON-CONTINOUS (RESPIRATOR)

Model Number 510M

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2018

Event Type  malfunction  

Event Description

The manufacturer received a report from an end user that the power supply to a continuous positive airway pressure (cpap) device was emitting smoke and was physically damaged.There was no patient harm or injury reported.The cpap device is approximately 10 years old and is no longer manufactured, but the age of the power supply and cord is unknown.The user was advised by the manufacturer to discard the power supply and contact his provider for replacement.The manufacturer has made numerous attempts to contact the user and provider for additional information and for return of product.To date, no further information has been provided and no product has been received for investigation.The respironics remstar auto m series system is a cpap device designed for the treatment of obstructive sleep apnea only in spontaneously breathing patients weighing (b)(6).This is not a life support device.Labeling instructs the user that if there are unexplained changes in the performance of the device their provider should be contacted.Additionally, the user is cautioned to periodically inspect electrical cords, cables, and the power supply for damage or signs of wear, and to discontinue use and replace if damaged.The manufacturer is unable to confirm the user's allegation.Based on the information available, the manufacturer concludes no further action is necessary at this time.If further information becomes available, or if the device is returned for investigation, the manufacturer will file a supplemental report.

• Brand Name: REMSTAR AUTO M SERIES AFLEX
• 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: adam price ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 8408573
• MDR Text Key: 138405206
• Report Number: 2518422-2019-00514
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• PMA/PMN Number: K041010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 510M
• Device Catalogue Number: 510M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2009
• 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: 62 YR