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

Model Number DSXHCP

Device Problem Insufficient Information (3190)

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

Event Date 10/12/2023

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a philips cpap device's sound abatement foam.The manufacturer received information allegation of unknown.The patient required no medical intervention.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

Due to a discrepancy with the customer reported serial number of the humidifier compared to the base device units registered to the customer, the model and serial number of the base device is unknown.Additional information is not available at this time.H3 other text : device not returned to manufacturer.

• Brand Name: DREAMSTATION HUMID
• 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: 18822422
• MDR Text Key: 336790034
• Report Number: 2518422-2024-11002
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,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

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSXHCP
• Device Catalogue Number: DSXHCP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2016
• 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