MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO CPAP W/HUM/HT/WIFI, DOM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX500T11W

Device Problems Contamination (1120); Smoking (1585); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2021

Event Type  malfunction  

Event Description

The manufacturer became aware of an allegation of a thermal event occurring to the dc power supply and the dc power input of the continuous positive airway pressure (cpap) device.The user reported the unit stopped working, he noticed a burning plastic odor and a thermal event on the power supply at the power inlet port on the cpap.There was no patient harm or injury.The manufacturer's investigation is on-going.Upon completion of the investigation, a follow up report will be filed.

Manufacturer Narrative

The manufacturer received the cpap only for evaluation.The manufacturer was able to duplicate smoking at the power port when a known good power supply was plugged into the device.The device had evidence of rust, corrosion and water ingress to the dc input connector and the blower assembly.There was no evidence of thermal damage internally to the device.The observed damage was most likely caused by water/liquid ingress to the dc input power connection and likely to the dc power supply output connector.The user is cautioned "contact your health care professional if symptoms of sleep apnea recur.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." based on the device evaluation, the manufacturer concludes that no further action is necessary at this time.

• Brand Name: DREAMSTATION AUTO CPAP W/HUM/HT/WIFI, DOM
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 11378560
• MDR Text Key: 233495156
• Report Number: 2518422-2021-00550
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959034129
• UDI-Public: 00606959034129
• Combination Product (y/n): N
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11W
• Device Catalogue Number: DSX500T11W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1