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

Model Number DSX500H11W

Device Problems Corroded (1131); Degraded (1153)

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

Event Date 12/25/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : returned to third party service center.

Event Description

The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The device was returned to third party service center for service.There was no patient harm or injury reported.There was no report of medical intervention.A dream station auto cpap device was returned to a third-party service center for service.During the evaluation of the device, the third-party service center visually inspected the device and found evidence of foam degradation.In addition, there were multiple error codes observed due to a failed pca component.Error#200 (err_rtos_abort_er ror), error#53 (err_comp_log_sem_ timeout), error#83 (err_fsens_unable_t o_obtain_bus), error#94 (err_rtc_stopped), error#87 (err_flow_sensor_b us), and error#93 (err_rtc_value).In addition to the above findings, there was also corrosion found in the connector of the device.The device was scrapped.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• Brand Name: DREAMSTATION 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: 18606668
• MDR Text Key: 334099695
• Report Number: 2518422-2024-04979
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: DSX500H11W
• Device Catalogue Number: DSX500H11W
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1