MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC DREAMSTATION 2 ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520H11C

Device Problem Excessive Heating (4030)

Patient Problems Bacterial Infection (1735); Choking (2464)

Event Date 11/18/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging a devastation 2 advanced auto cpap contributed to repeat sinus infections of a user.The user alleges the water runs out in a few hours and the device begins to smell like burnt plastic and metal because the heater continues to heat which causes the user to wake up choking.The user reportedly was prescribed antibiotics and cough syrup.There was no report of serious patient harm or injury.The device has not yet been returned to the manufacturer.The investigation is on-going.A final report will be submitted when the investigation has been completed.

Manufacturer Narrative

Not returned to manufacturer.

Manufacturer Narrative

The manufacturer previously reported information alleging a dreamstation 2 advanced auto cpap contributed to repeat sinus infections of a user.The user alleges the water runs out in a few hours and the device begins to smell like burnt plastic and metal because the heater continues to heat which causes the user to wake up choking.The user reportedly was prescribed antibiotics and cough syrup.There was no report of serious patient harm or injury.In the previous report, section h1 type of reportable event, was inadvertently selected as "other".It has been corrected to "serious injury" on this report.

Manufacturer Narrative

The manufacturer previously reported information alleging a dreamstation 2 advanced auto cpap contributed to repeat sinus infections of a user.The user alleges the water runs out in a few hours and the device begins to smell like burnt plastic and metal because the heater continues to heat which causes the user to wake up choking.The user reportedly was prescribed antibiotics and cough syrup.There was no report of serious patient harm or injury.Additional information received from the patient indicates that they experienced coughing, throat infection, and congestion.With the help of their provider, the replacement device was exchanged for a new device.In the previous report, section h1 type of reportable event, was inadvertently selected as "serious injury".It has been corrected to "product problem" on this report.Product investigation lab (pil) received dreamstation 2 advanced auto cpap.Pil confirmed the device powered up, provided airflow, had good heated tubes, and heater plate.During review of the error logs, pil determined the device was likely reset prior to pil receipt.There were 19 errors logged.These errors were not reproduced with continued usage, and it was concluded that these errors do not impact the investigation.Furthermore, during the investigation, pil observed that the ui panel was not seated correctly, and the therapy button had moved from its proper location to under the ui panel, on top of the pca board.The device was also missing the inlet/outlet seal.An unknown dust contaminant was observed on the ui panel, top enclosure, center enclosure and blower.The bottom screws were observed to be corroded, suggesting liquid ingress to them.Evidence of liquid ingress was observed to the iso port, blower, and blower box.Moreover, hair-like particles were observed on the blower seal and bottom-enclosure.Pil was unable to directly address the symptoms or complaints.

• Brand Name: DREAMSTATION 2 ADV AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 15976046
• MDR Text Key: 305494791
• Report Number: 2518422-2022-101800
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520H11C
• Device Catalogue Number: DSX520H11C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Female