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

Model Number UDSX700S11F

Device Problem Contamination (1120)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 03/18/2024

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The patient has alleged particles in device, throat and nose irritation.There was no report of serious or permanent harm or injury.The device has not yet been returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

Device not returned to manufacturer.

• Brand Name: REP DREAMSTATION AUTO BIPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIR ATOR)
• 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: 18951891
• MDR Text Key: 338264980
• Report Number: 2518422-2024-14725
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UDSX700S11F
• Device Catalogue Number: UDSX700S11F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/14/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1