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

Model Number UDSX500S11F

Device Problem Degraded (1153)

Patient Problems Headache (1880); Sore Throat (2396); Cough (4457); Unspecified Respiratory Problem (4464); Unspecified Ear or Labyrinth Problem (4474)

Event Date 02/23/2024

Event Type  malfunction  

Event Description

The manufacturer received information in relation to a dreamstation auto cpap device.The patient has alleged sore throat, headache, raspy throat, cough and earaches.The patient also noticed that she had mold and mildew in on the silicon seal of the humidifier.Medical intervention happened, the doctor gave the patient an antibiotic and it helped while she was using it but now it is all back again since the antibiotic has ended.The device is currently at the third party service center but the evaluation has not yet begun.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18805570
• MDR Text Key: 336510961
• Report Number: 2518422-2024-10606
• 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: 02/29/2024
• 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: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/25/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Female