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

Model Number DSX500H11C

Device Problem Degraded (1153)

Patient Problems Headache (1880); Sore Throat (2396); Renal Impairment (4499)

Event Date 10/01/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging black particles in hose related to a cpap device's sound abatement foam.The patient alleges to have headaches, kidney disease, sore throat.There is no report of medical intervention being required.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously received information alleging black particles in hose related to a cpap device's sound abatement foam.The patient alleges to have headaches, kidney disease, sore throat.There is no report of medical intervention being required.The device was returned to the manufacturer's product investigation laboratory for investigation.An internal visual inspections of the device was completed by the manufacturer and found evidence of sound abatement foam degradation.The device's downloaded event log was reviewed by the manufacturer and found 4 errors.The manufacturer concludes there was evidence of sound abatement foam degradation.In this report, section d9, g3, h3, h6 has been updated or corrected.

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC.; 1001 murry ridge ln; 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: 14502539
• MDR Text Key: 292689795
• Report Number: 2518422-2022-12483
• 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: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500H11C
• Device Catalogue Number: DSX500H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2018
• 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): Other