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

Model Number DSX520H11C

Device Problems Failure to Shut Off (2939); Excessive Heating (4030)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 10/01/2022

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device was scrapped.

Event Description

The manufacturer became aware of allegations, that a dreamstation 2 became hot, would not shut off on its own and the user had to manually unplug it.Additionally, the humidifier was getting very hot, and it was irritating her nose and throat.The user also alleges the device has burnt her nightstand.The user also stated when she wakes up, she complains of a dry scratchy nose and throat.The user's physican recommended throat lozenges and nasal lubricant.The device was replaced for the user and the suspected device was scrapped.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• Brand Name: DS2ADV 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: 17631906
• MDR Text Key: 322061347
• Report Number: 2518422-2023-20929
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• 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: 11/14/2022
• 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 Age: 57 YR
• Patient Sex: Female