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

Model Number CAX521H12C

Device Problems Backflow (1064); Complete Loss of Power (4015); Excessive Heating (4030)

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

Event Date 05/16/2023

Event Type  malfunction  

Event Description

The manufacturer received information alleging a dreamstation 2 advanced auto cpap stopped working after five minutes, became really hot, and is no longer working after the first use.There was no report of smoke, flames, voids, or exposed ac wires.There was no report of patient harm or injury.There was no report of medical intervention.The device was returned for evaluation.During the evaluation of the device, the technician was able to confirm the customer's complaint of the device stopped by itself after five minutes due to thermal damage to the pca from water ingress.The technician was unable to retrieve the error log data.The device was returned to the manufacturer's product investigation lab for further evaluation due to the thermal damage.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

Manufacturer Narrative

The manufacturer previously reported the patient identifier as (b)(6) in section a1.After review, the patient identifier should have been left blank.

• Brand Name: DREAMSTATION 2 ADVANCED 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: 18545675
• MDR Text Key: 333273860
• Report Number: 2518422-2024-03573
• 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: Foreign,Consumer,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• 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: 04/26/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1