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

Model Number DSX500T11C

Device Problem Moisture or Humidity Problem (2986)

Patient Problem Tooth Fracture (2428)

Event Type  Injury  

Event Description

The manufacturer became aware that a user alleges tooth loss due to his humidifier not heating with his cpap.The humidifier does not show connected to his device.The device has yet to be returned to the manufacturer for evaluation.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer became aware that a user alleges tooth loss due to his humidifier not heating with his cpap.The humidifier does not show connected to his device.Even though the humidifier base did not heat, the water in the humidifier would act as a passover humidifier.The manufacturer has not received the devices for investigation.Despite multiple requests, no devices have been returned.If further information becomes available, an additional report will be filed.If further information becomes available, an additional report will be filed.The manufacturer concludes no further action is needed at this time.

• 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 15206 ; 2673970028
• MDR Report Key: 12514018
• MDR Text Key: 272737258
• Report Number: 2518422-2021-02338
• 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,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: HUMIDIFIER S/N (B)(6); HUMIDIFIER S/N (B)(6) ; HUMIDIFIER S/N (B)(4)
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Male