MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO CPAP W/HUM/HT/CELL,DOM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX500T11C

Device Problems Degraded (1153); Power Problem (3010)

Patient Problems Itching Sensation (1943); Sore Throat (2396); Cough (4457)

Event Date 07/06/2021

Event Type  malfunction  

Manufacturer Narrative

H3 other text : not returned.

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 stated that he/she is having nasal/throat irritation or soreness.The patient also states that he/she experiencing dry itchy throat and coughing.The patient said that the device will not turn on or the device is not functioning.There was no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device was returned to the manufacturer, but the investigation has not yet begun.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

Correction for h3: device evaluated by manufacturer? in reason from device not eval.From other - not returned to device evaluation anticipated, but not yet begun.

• Brand Name: DREAMSTATION AUTO CPAP W/HUM/HT/CELL,DOM
• 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: 18142783
• MDR Text Key: 328241047
• Report Number: 2518422-2023-30448
• 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

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?: No
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 08/05/2021
• Supplement Dates FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/28/2020
• 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
• Patient Sex: Female