MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION 2 ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number FRX521H14C

Device Problems Device Emits Odor (1425); Complete Loss of Power (4015); Excessive Heating (4030)

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

Event Date 02/11/2023

Event Type  malfunction  

Event Description

The manufacturer received information alleging that a dreamstation 2 advanced auto cpap device would not power on and that a burnt odor was observed.There was no report of patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for evaluation.During the evaluation of the device, the reported symptoms were confirmed.The device was unable to be powered on; therefore, functional testing was unable to be performed.In addition, an electrical burning odor was observed.No error log information was able to be obtained.A visual external and internal inspection of the device was performed which found the following: under side of the display had black burn marks on it.Pca (printed circuit assembly) had q2 (phase a) of the motor circuitry was blown apart and the surrounding components had black burn marks along with white residue (potential mineral deposits) and green and pink colors indicating possible corrosion.The underside of q2 of the pca had potential black burn marks on it.D19 area of the pca had white residue (potential mineral deposits).C53 had white residue (potential mineral deposits) on it.Potential black burn marks on the inlet/outlet seal.The iso port tube section that sits under the q2 portion of the pca, had a potential black burn mark and was melted.All the potential mineral deposits on the pca, signal moisture was inside of the device and showed signs of corrosion most likely caused by condensation.Blower motor had slight dust-like contaminations and potential small hairs on top of it.White potential mineral deposit towards the output end of the iso port tube.Small white spots of potential mineral deposits were in the bottom of the enclosure under the blower box.Tiny unknown black and white specs of contamination at the air input and bottom of the blower box along with tiny potential hairs.White residue (potential mineral deposits) in the bottom enclosure in the corners of the heater plate assembly.Potential mineral deposits in the bottom enclosure signal moisture inside of the device.The evaluation of device concluded that there was visible damage and functionality failures of the device that are most likely due to external conditions.Potential moisture getting into the device where the pca is located is believed to be the primary cause of the reported symptoms.

Manufacturer Narrative

Corrective and preventative actions have been opened by the manufacturer to address the water ingress identified upon investigation.

• Brand Name: DREAMSTATION 2 ADV AUTO CPAP
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16878627
• MDR Text Key: 314663743
• Report Number: 2518422-2023-10535
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959062757
• UDI-Public: 00606959062757
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K200480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: FRX521H14C
• Device Catalogue Number: FRX521H14C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1