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

Model Number DSX520H11C

Device Problem Decrease in Pressure (1490)

Patient Problems High Blood Pressure/ Hypertension (1908); Sleep Dysfunction (2517)

Event Date 11/16/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging an end user was hospitalized while using the dreamstation 2 advanced auto cpap device due to poor sleep, snoring, and a new onset of hypertension because the device was not producing enough pressure, even after adjusting the settings.There was no report of serious patient harm or injury.The device has not yet been returned to the manufacturer.The investigation is on-going.A final report will be submitted when the investigation has been completed.

Manufacturer Narrative

Not returned to manufacturer.

Manufacturer Narrative

The manufacturer previously reported information alleging an end user was hospitalized while using the dreamstation 2 advanced auto cpap device due to poor sleep, snoring, and a new onset of hypertension because the device was not producing enough pressure, even after adjusting the settings.There was no report of serious patient harm or injury.In the previous report, section h1 type of reportable event, was inadvertently selected as "other".It has been corrected to "serious injury" on this report.

• Brand Name: DREAMSTATION 2 ADV 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: 15976107
• MDR Text Key: 306109057
• Report Number: 2518422-2022-101795
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520H11C
• Device Catalogue Number: DSX520H11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male