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

Model Number DSX500T11C

Device Problems Degraded (1153); Device Emits Odor (1425); Noise, Audible (3273); Unexpected Shutdown (4019)

Patient Problems Sore Throat (2396); Taste Disorder (4422); Unspecified Respiratory Problem (4464)

Event Date 08/25/2021

Event Type  malfunction  

Event Description

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 patient alleges weird taste in his mouth when using the machine, scratchy throat, nasal/throat irritation or soreness.The patient also alleges odor coming from machine, randomly shut off on its own, makes a whistling noise and does not close properly.There was no report of serious patient harm or injury.There was no medical intervention required by the patient.The device was returned and evaluated by the manufacturer.The internal part of the device was inspected visually.The device's downloaded logs were reviewed by the manufacturer and 0 error was found.The device software was upgraded and the error log was cleared.The device status was recertified.The unit passed the final test.The manufacturer concludes that there was no evidence of visible foam degradation.

• 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 15208 ; 4125423300
• MDR Report Key: 17876264
• MDR Text Key: 324982570
• Report Number: 2518422-2023-25290
• 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

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: DSX500T11C
• Device Catalogue Number: DSX500T11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1