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

Model Number UDSX500S11F

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : the device has not been returned to the manufacturer for analysis.

Event Description

The manufacturer was contacted about a rep dreamstation auto cpap device regarding the allegation of a burning electrical smell coming through the tube and the mask.No mention of smoke, exposed wiring, or evidence of melting, warping or voids/gaps in the enclosure.There was no serious injury or harm mentioned by the patient; neither was there any medical intervention specified.

• Brand Name: REP 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: 18546147
• MDR Text Key: 333277979
• Report Number: 2518422-2024-03593
• 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
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UDSX500S11F
• Device Catalogue Number: UDSX500S11F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/05/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male