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

Model Number DSX520H11C

Device Problems Overheating of Device (1437); Excessive Heating (4030)

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

Event Date 08/19/2022

Event Type  malfunction  

Manufacturer Narrative

H3 other text : sent to a third-party service center.

Event Description

The manufacturer received information alleging the dreamstation 2 advanced auto cpap device.The patient alleges the heater plate getting hot to touch.There was no report of patient harm or injury.During the evaluation of the device at the third-party service center, the device was visually inspected and found to fail the test post reboot.In addition to the above findings, it was also determined that ui bezel physical damage.The device was scrapped.The manufacturer is submitting a final report at this time.

Manufacturer Narrative

The manufacturer previously received information alleging the dreamstation 2 advanced auto cpap device.The patient alleges the heater plate getting hot to touch.There was no report of patient harm or injury.During the evaluation of the device at the third-party service center, the device was visually inspected and found to fail the test post reboot.In addition to the above findings, it was also determined that ui bezel physical damage.The device was scrapped.The manufacturer is submitting a final report at this time.The manufacturer is submitting a correction report for section h: problem code.

• 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: 17743335
• MDR Text Key: 323365577
• Report Number: 2518422-2023-22837
• 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: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: DSX520H11C
• Device Catalogue Number: DSX520H11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 08/19/2022
• Supplement Dates FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/05/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1