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

Model Number DSX500H11

Device Problem Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/30/2019

Event Type  malfunction  

Event Description

An end user reported a thermal event occurred to the power cord to his continuous positive airway pressure (cpap) device while in use.The user alleged he saw sparking and flames, which he extinguished by blowing them out.There was no harm or injury reported.The durable medical equipment provider also reported to the manufacturer that the user had a non-approved power supply in use with the device when they assessed it at the home.The manufacturer received the cpap device, associated humidifier, and the power supply/cord for investigation that is approved for use with the device.The non-approved power supply/cord was not returned.There was evidence of thermal damage and deformation to the power supply dc output connector and dc power supply.There was also evidence of water ingress at the dc port and internally.There was no evidence of thermal damage internally.The finding of water ingress is likely a result of the devices being moved or mishandled with water still in the humidifier chamber.The philips respironics dreamstation systems deliver positive airway pressure therapy for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing over 30 kg (66 lbs).It is for use in the home or hospital/institutional environment.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." product labeling provides user care and handling instructions to prevent water ingress from occurring or affecting the operation of the device."when installing the water tank, do not allow any water to spill into the humidifier or therapy device.Do not fill the water tank above the maximum fill line.If the water tank is overfilled, water may leak into the therapy device, humidifier, or onto your furniture.Damage to the humidifier or therapy device may occur.Remove the tank, empty all water, and replace the empty tank before transporting the humidifier base.Do not attempt to fill the water tank while it is still inside the humidifier.To avoid spilling, do not disconnect the humidifier from the therapy device with water in the tank.Remove the water tank from the humidifier before disconnecting the therapy device.Do not move the humidifier while the water tank has water in it." based on the available information, the manufacturer concludes that no further action is needed.

• Brand Name: DREAMSTATION AUTO CPAP W/HUMID, DOM
• 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: adam price ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 9627904
• MDR Text Key: 181181330
• Report Number: 2518422-2020-00209
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959022478
• UDI-Public: 00606959022478
• Combination Product (y/n): N
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500H11
• Device Catalogue Number: DSX500H11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Date Manufacturer Received: 01/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: HUMIDIFIER H160649358DCA
• Patient Age: 71 YR
• Patient Sex: Male