MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION 2 ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number CAX521H12C

Device Problems Device Emits Odor (1425); Complete Loss of Power (4015); Excessive Heating (4030)

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

Event Date 04/05/2023

Event Type  malfunction  

Manufacturer Narrative

Corrective and preventative actions have been opened by the manufacturer to address the water ingress identified upon investigation.

Event Description

The manufacturer received information alleging that a dreamstation 2 advanced auto cpap device would not power on and that a burnt odor was observed.There was no report of patient harm or injury.The device was received by the manufacturer for evaluation.The repair technician found evidence of thermal damage to the pca at q2.In addition, no power to the unit and a burning odor was confirmed.Visual examination found thermal stress to the lcd touch display and there was evidence of water ingress to the pca and the blower assembly.

• Brand Name: DREAMSTATION 2 ADV 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: 16878957
• MDR Text Key: 314973143
• Report Number: 2518422-2023-10544
• 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: 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: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CAX521H12C
• Device Catalogue Number: CAX521H12C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2023
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male