MAUDE Adverse Event Report: RESPIRONICS, INC. DS2ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520H11C

Device Problems Failure to Power Up (1476); Noise, Audible (3273); Excessive Heating (4030)

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

Event Date 11/09/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging the dreamstation 2 advanced auto cpap device has loud popping, and extremely hot to touch, and dropped the unit on the floor.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 the technician opened the device and observed that the humidifier and the cpap base were not snug.The technician put the humidifier and the cpap base back together and powered the device using the customer supplied power supply.The device powered up but was very loud and had little airflow.The technician found the inlet/outlet seal was upside down and crooked.The technician put the inlet/outlet seal on properly and noticed the device was very quiet.The technician verified that airflow, heater plate, and the pil supplied heated tube were working.A visual external and internal inspection of the device was performed and observed the following: two top screws of the top enclosure had white residue (potential mineral deposits) on the tops of each of them and one screw had white residue (potential mineral deposits) on its threads.One screw holding down the pca (printed circuit assembly) had white residue (potential mineral deposits) on the top of it.Pca components near r153 had white residue (potential mineral deposits) and black burn marks on them.There was white residue (potential mineral deposits), black burn marks and potential brown corrosion near the components of q2 (phase a) and q3 (phase b) of the motor circuitry.There was white residue (potential mineral deposits) potential brown corrosion at the components of u10 and near r198, r153 and c113.There was white residue (potential mineral deposits) and unknown black and brown marks at vled and surrounding components.There was a black burn mark at the trace near u3.There was potential brown corrosion at the traces on the opposite side of q3 of the pca.There was white residue (potential mineral deposits) and black burn marks at c193 and surrounding circuitry.The blower box lid had two screws with white residue (potential mineral deposits) on the top of them.The blower motor brass nut had white residue (potential mineral deposits) and potential green corrosion on top of it.The evaluation of the device concluded that the technician was not able to confirm most of the complaints but was able to confirm a noisy operation.Pil was not able to address the symptoms specified.There is visible damage and functionality failures of the device that is 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 customer complaint.

• Brand Name: DS2ADV 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: 17594460
• MDR Text Key: 321630106
• Report Number: 2518422-2023-20241
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Date Manufacturer Received: 11/09/2021
• 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 Age: 55 YR
• Patient Sex: Male