MAUDE Adverse Event Report: RESPIRONICS, INC. DS2ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520H11C

Device Problems Leak/Splash (1354); Excessive Heating (4030)

Patient Problem Headache (1880)

Event Date 11/19/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging the dreamstation 2 advanced auto cpap device displaying error service required.The humidifier is not heating at points causing dryness and severe headache.The plate is too hot, and water is leaking everywhere.There was no report of patient harm or injury.The device has not yet been returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Manufacturer Narrative

The manufacturer received information alleging the dreamstation 2 advanced auto cpap device displaying error service required.The humidifier is not heating at points causing dryness and severe headache.The plate is too hot, and water is leaking everywhere.There was no report of patient harm or injury.The device has not yet been returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Based on the information available, there is no evidence indicating a reportable malfunction occurred.An mdr is not required for this complaint.

• Brand Name: DS2ADV 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: 17600982
• MDR Text Key: 321722260
• Report Number: 2518422-2023-20520
• 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: 08/23/2023
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1