MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO CPAP, GER; VENTILATORY, NON-CONTINUOUS (RESPIRATOR),

Model Number DEX500S13

Device Problem Use of Device Problem (1670)

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

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

The device was functionally checked after the event and it was determined the device passes functional testing.There was no thermal or physical damage was observed.Device is not being returned for investigation.

Event Description

The manufacturer became aware of an allegation of a thermal event to a resmed face mask in use with a continuous positive airway pressure (cpap) device and liquid oxygen bled in to the patient circuit.The user reportedly applied face cream before placing the mask on.During the night, the user woke up to go to the restroom, turned off the cpap device, but kept the liquid oxygen source on.The thermal event was noted shortly after.There was no harm or injury reported.Photos of the cpap and accessories were received from the distributor showing there was no thermal damage to anything other than the resmed face mask and a pillow under the mask.It was determined that the user did not have a recommended one-way valve (pressure valve) in the circuit.A third party also confirmed the cpap device passed all testing after the event, with no operational issues noted.The root cause of the thermal event to the face mask is most likely due to a chemical reaction between the face cream and the oxygen.The cpap device did not cause or contribute to the event.Labeling included with the cpap device warns the user that oxygen supports combustion.When using oxygen with this system, the user should turn the device on before turning on the oxygen, and turn the oxygen off before turning the device off.This will prevent oxygen accumulation in the device.When the device is not in operation and the oxygen flow is left on, oxygen delivered into the tubing may accumulate within the device's enclosure.Oxygen accumulated in the device enclosure will create a risk of fire.When using oxygen with this system, a philips respironics pressure valve must be placed in-line with the patient circuit between the device and the oxygen source.The pressure valve helps prevent the back-flow of oxygen from the patient circuit into the device when the unit is off.Failure to use the pressure valve could result in a fire hazard.The manufacturer concludes there is no further action required and that failure to follow instructions on the use of oxygen with the cpap device and to heed warnings associated with oxygen usage caused the event.

• Brand Name: DREAMSTATION AUTO CPAP, GER
• Type of Device: VENTILATORY, 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: 11368676
• MDR Text Key: 233244621
• Report Number: 2518422-2021-00536
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959024090
• UDI-Public: 00606959024090
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/23/2021

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: DEX500S13
• Device Catalogue Number: DEX500S13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 02/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2018
• 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