MAUDE Adverse Event Report: RESPORINOC INC BIPAP PRO BI-FLEX; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	DS660TBT
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain bipap, and mechanical ventilator devices.The manufacturer received information alleging particles in airway from device.There was no report of patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
Additional information was received on mar 09, 2023, and section h10 should be reported as: the manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain bipap, and mechanical ventilator devices.The manufacturer received information alleging particles in airway from device.There was no report of patient harm or injury.After the frist attempt to have the device and components returned for evaluation, customer stated that device was not availbel for i am using device i am very discouraged waiting for my new device arrival and peace of mind.Already the manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.Section h6 updated in this report.

• Brand Name: BIPAP PRO BI-FLEX
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPORINOC INC; 101 murry ridge lane; murrysville, pa PA 15668
• Manufacturer (Section G): RESPORINICS, INC; 1001 murry ridge lane; murrysville,pa PA 15668
• Manufacturer Contact: rosko melissa ; 6501 living place; pittisburgh,pa, PA 15206 ; 7243512041
• MDR Report Key: 15476505
• Report Number: 2518422-2022-82556
• Device Sequence Number: 6020269
• Product Code: BZD
• UDI-Device Identifier: 00606959031173
• UDI-Public: 00606959031173
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DS660TBT
• Device Catalogue Number: DS660TBT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 88058
• Patient Sequence Number: 1
• Patient Sex: Unknown