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

Model Number DSX700H11

Device Problems Degraded (1153); Scratched Material (3020)

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

Event Date 01/17/2023

Event Type  malfunction  

Event Description

A device was returned to a third-party service center in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.During the evaluation of the device at the third-party service center, the device was visually inspected and visible foam particles were observed.Additionally, the patient's complaint was confirmed and technical findings: missing left door, damaged ui panel (scratched), damaged top enclosure (scratch) were found.The device was corrected.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

Manufacturer Narrative

H3 other text : device serviced by a third-party service center.

• 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: 18935459
• MDR Text Key: 338043134
• Report Number: 2518422-2024-14357
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959022539
• UDI-Public: 00606959022539
• 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: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: DSX700H11
• Device Catalogue Number: DSX700H11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/24/2017
• 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