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

Model Number DSX520H11C

Device Problems Thermal Decomposition of Device (1071); Corroded (1131); Electrical /Electronic Property Problem (1198); Moisture Damage (1405); Device Emits Odor (1425); Fumes or Vapors (2529); Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/18/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging a ds2adv auto cpap has a "service required" message, and the patient states the device is not working.This was an out of box failure.There was no harm or injury reported.The patient attempted instructed troubleshooting, but the issue was not resolved.The ventilator was returned to the manufacturer for evaluation and the customer¿s complaint was confirmed.Error code e-15 and e-19 were noted in the error log.The therapy pca and lcd display were replaced due to thermal and water ingress damage.The system firmware was updated.The device was sent to the philips investigation lab (pil) for further investigation.During the investigation the device was powered on, and a burning odor was then detected, and an unknown dust contaminant was observed on the water tank.Black dust consistent with burning was observed on the ui panel.The ui cable was observed to have burn marks on it.An unknown dust contaminant was observed on the top enclosure, as well as evidence of liquid ingress.The q4 on the pca appeared to be burnt, and the pca was observed to have other areas of corrosion, suggesting liquid ingress.In addition, an unknown white dust contaminant was observed in the inlet of the blower box, on the blower and blower seal confirming debris in the airpath.The brass nut on the blower had corrosion on it.Evidence of liquid ingress was observed on the blower.An unknown dust contaminant and liquid ingress was observed on the bottom enclosure.Pil is unable to directly address the issues.Pil can confirm the device is not working properly.

• 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: 18895329
• MDR Text Key: 337562265
• Report Number: 2518422-2024-13688
• 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: Consumer
• Reporter Occupation: Non-Healthcare 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: DSX520H11C
• Device Catalogue Number: DSX520H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1