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

Model Number DS760TS

Device Problem Degraded (1153)

Patient Problems Dyspnea (1816); Fatigue (1849); Cough (4457); Nodule (4551)

Event Date 03/22/2024

Event Type  Injury  

Manufacturer Narrative

H3 other text : the device has not been returned to the manufacturer for analysis.

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 user of the device alleges they found out about the recall via a friend and is confused as they were not notified.The patient registered their device and allegedly was told because the device is more than 5 years old, they were not eligible for a replacement device.The manufacture informed the patient the information they received was incorrect.The patient alleges excessive coughing, thick mucus from the lungs and sinuses, fatigue and shortness of breath, and lung nodules.The patient states the allergy shots are not working.Aside from the mention of allergy shots, there is no other medical intervention specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: BIPAP AUTO BIFLEX
• 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: 19016965
• MDR Text Key: 339081335
• Report Number: 2518422-2024-16767
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959006027
• UDI-Public: 00606959006027
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS760TS
• Device Catalogue Number: DS760TS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/11/2015
• 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
• Patient Outcome(s): Other