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

Model Number DSX500S11

Device Problem Degraded (1153)

Patient Problems Fatigue (1849); Cancer (3262); Swollen Lymph Nodes/Glands (4432)

Event Date 04/01/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused the patient to experience chronic lymphocytic leukemia, enlarged lymph node and fatigue.The patient did receive medical intervention in the form of diagnostic testing, chemotherapy and hospitalization.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap and mechanical ventilator devices.The manufacturer previously received information alleging a cpap device's sound abatement foam became degraded and caused the patient to experience chronic lymphocytic leukemia, enlarged lymph node and fatigue.The patient did receive medical intervention in the form of diagnostic testing, chemotherapy and hospitalization.This notification and its severity was reviewed by the pms clinical expert due to the patient reporting enlarged lymph nodes on a chest, abdomen and pelvis ct scan, which were subsequently diagnosed as chronic lymphocytic leukemia (cll) and confirmed via lab testing.The patient also reports that the chest ct showed ground glass opacities (appearance) believed to be due to use of their device.The patient reports they stopped use of the device temporarily but returned to use due to recurrent symptoms of their underlying untreated sleep apnea while not using the device.This event is assessed as not related to the device in this case, and therefore is not a reportable injury.This event is assessed as not related to the device in this case.Based on the available information, the manufacture concludes no further action is necessary.There was no medical intervention required by the patient.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.Section h6 updated in this report.

• 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: 12628984
• MDR Text Key: 276355171
• Report Number: 2518422-2021-05223
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500S11
• Device Catalogue Number: DSX500S11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2019
• 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 Outcome(s): Hospitalization; Required Intervention; Other
• Patient Sex: Male