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

Model Number DSX520T11C

Device Problem Improper Flow or Infusion (2954)

Patient Problem Dry Mouth (4485)

Event Date 05/23/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device has not been returned to the manufacture.

Event Description

The manufacturer became aware of allegations, that a ds2adv auto cpap device the patient needs more moisture.Additionally, the patient stating that the machine is not working properly.Humidifier is irregular and not giving moisture to patient although the humidifier is set at max allowance.The patient mentioned that he is having a dry mouth.There was no report of serious patient harm or injury.Despite the three attempts, the device has not yet returned to the manufacturer for evaluation.There has been no response from the customer on the return of the device.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.; 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: 18093984
• MDR Text Key: 327708304
• Report Number: 2518422-2023-29422
• 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: 11/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520T11C
• Device Catalogue Number: DSX520T11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male