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

Model Number	DS660HBT
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Sore Throat (2396); Unspecified Respiratory Problem (4464)
Date of Event	08/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The patient alleged nasal/throat irritation or soreness.There was no report of serious or permanent 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
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 previously received information alleging an issue related to a bipap device's sound abatement foam.The pateint alleged nasal/throat irritation or soreness.There was no report of serious or permanant patient harm or injury.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.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.Section h6 updated in this report.Section d7a has been corrected / updated in this report.
Additional Manufacturer Narrative
Additional information was received on jul 19 , 2025 and section h10 should be reported as: the manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The patient alleged nasal/throat irritation or soreness.There was no report of serious or permanent patient harm or injury.The device was returned to the third-party service center for further evaluation.During the evaluation of the device at the third-party service center, the device was visually inspected and found no evidence of foam degradation.During the evaluation, secondary findings was not observed.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the third-party service center.There was 7 error codes found.The third-party service center concludes that they couldn't confirm the customer's allegation and there was no visible foam degradation and unit was scraped.Section h6 updated in this report.

• Brand Name: BIPAP PROBIFLEX
• 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: 15183908
• Report Number: 2518422-2022-67459
• Device Sequence Number: 17739987
• Product Code: BZD
• UDI-Device Identifier: 00606959031029
• UDI-Public: 00606959031029
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2025

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: DS660HBT
• Device Catalogue Number: DS660HBT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2022
• Supplement Date Received by Manufacturer: 05/29/2023; 07/19/2025
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 05/30/2023; 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2015
• 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