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

Model Number DSX700H11C

Device Problems Degraded (1153); Failure to Power Up (1476)

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

Event Date 07/11/2022

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device evaluated by 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 manufacturer received information alleging the device was not turning on or not functioning.There was no report of patient harm or injury.The device was sent to third party service center.During the evaluation of the device at the third-party service center, the device was visually inspected, and foam particles were observed in the device.  the service center concludes that the complaint was not confirmed since the device was not functioning and there was evidence of sound abatement foam degradation.

• Brand Name: DREAMSTATION AUTO BIPAP
• 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: 18189593
• MDR Text Key: 328741838
• Report Number: 2518422-2023-31337
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959025691
• UDI-Public: 00606959025691
• 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: Consumer
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX700H11C
• Device Catalogue Number: DSX700H11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/30/2018
• 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