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

Model Number DS760HS

Device Problem Material Deformation (2976)

Patient Problem Dyspnea (1816)

Event Date 03/06/2023

Event Type  malfunction  

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 visualization of particles in the air path.The patient alleges short ness of breath.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.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.

Manufacturer Narrative

The manufacturer previously reported information 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 visualization of particles in the air path.The patient alleges difficulty breathing/shortness of breath.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• 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: 16570559
• MDR Text Key: 311561404
• Report Number: 2518422-2023-07085
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959006010
• UDI-Public: 00606959006010
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS760HS
• Device Catalogue Number: DS760HS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/10/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1