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

Model Number DS650S

Device Problem Degraded (1153)

Patient Problems Headache (1880); Inflammation (1932); Liver Damage/Dysfunction (1954); Dizziness (2194); Cardiovascular Insufficiency (4445); Unspecified Respiratory Problem (4464)

Event Date 08/28/2023

Event Type  Injury  

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 respiratory tract irritation, dizziness, headache, inflammatory response, liver disease/toxicity, reduced cardiopulmonary reserve, and bilateral vocal cord paralysis.Medical intervention was not specified.The manufacturer was made aware of this complaint through a representative of the customer.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

• Brand Name: BIPAP PRO 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: 17826592
• MDR Text Key: 324385425
• Report Number: 2518422-2023-24696
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091319
• 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

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS650S
• Device Catalogue Number: DS650S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2010
• 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): Disability