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

Model Number CAX521H12C

Device Problems Device Emits Odor (1425); Patient-Device Incompatibility (2682)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device serviced by third party service center.

Event Description

The manufacturer received information alleging a dreamstation 2 advanced auto cpap turns on for a few seconds and then the device work for a few seconds.As result, the device has a burning/melting smell and gets really hot.The reported added that device comes on and then shuts off.The internal investigation of the device found charring on lcd panel as well as water spots on the lcd panel.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.

• 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: 18704200
• MDR Text Key: 336212406
• Report Number: 2518422-2024-06994
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K200480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• 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: 02/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CAX521H12C
• Device Catalogue Number: CAX521H12C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male