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

Model Number DSX500T11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Atrial Fibrillation (1729); Chest Pain (1776); Dyspnea (1816); Headache (1880); Nausea (1970); Vertigo (2134); Unspecified Heart Problem (4454); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.There was no report of patient harm or injury this issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

The manufacturer was previously received information alleging an issue related to a cpap device's sound abatement foam.There was no report of patient harm or injury.In the previously submitted report section b5 was incomplete, section b5 is- the patient also alleged visualization of particles and having headaches, nausea, vertigo, eye irritation, red and swollen skin on face, heavy chest, increased shortness of breath, worsened afib, heart ablation.The device was returned to the manufacturer's product investigation laboratory for investigation.An internal visual inspection of the device was completed by the manufacturer.The manufacturer found evidence of fine black hair like contamination on exterior of iso port, fine white dust like and short hair like contamination on blower, circular marring of interior surface of blower box lid, fine black dust like contamination consistent with keratin around blower seal, fluid ingress and mineral deposits on blower and in blower box.The manufacturer found no evidence of sound abatement foam degradation/breakdown.The device was hooked up to power supply, airflow was verified and the device operated properly.The device's event logs were downloaded and reviewed.The manufacturer found no errors logged.The manufacturer concludes there was evidence of fine black hair like contamination on exterior of iso port, fine white dust like and short hair like contamination on blower, circular marring of interior surface of blower box lid, fine black dust like contamination consistent with keratin around blower seal, fluid ingress and mineral deposits on blower and in blower box.The manufacturer confirmed there was no evidence of sound abatement foam degradation/breakdown.

• Brand Name: DREAMSTATION 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 15206 ; 2673970028
• MDR Report Key: 12978917
• MDR Text Key: 282208132
• Report Number: 2518422-2021-07978
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11C
• Device Catalogue Number: DSX500T11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Sex: Female