MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC DREAMSTATION 2 ADVANCED AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520H11C

Device Problem Moisture or Humidity Problem (2986)

Patient Problem Sore Throat (2396)

Event Date 01/06/2023

Event Type  Injury  

Manufacturer Narrative

Device was not returned to manufacturer.

Event Description

The manufacturer became aware of an allegation that a user of a dreamstation 2 advanced auto cpap's humidifier was not working.The user states it was not using water and his throat was very dry, causing a throat infection which required antibiotics.Despite multiple attempts to troubleshoot, user is requesting a replacement humidifier.A request was sent to remediation for replacement.No device has returned for investigation.This will be an initial final report.If further information becomes available, an additional report will be filed.The manufacturer concludes no further action is needed at this time.

Manufacturer Narrative

The manufacturer became aware of an allegation that a user of a dreamstation 2 advanced auto cpap's humidifier was not working.The user states it was not using water and his throat was very dry, causing a throat infection which required antibiotics.Despite multiple attempts to troubleshoot, user is requesting a replacement humidifier.A request was sent to remediation for replacement.No device has returned for investigation.This will be an initial final report.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 2 ADVANCED AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16198504
• MDR Text Key: 307629894
• Report Number: 2518422-2023-02045
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200480
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DSX520H11C
• Device Catalogue Number: DSX520H11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/15/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Male