MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP S/T C SERIES DOM 30; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	1060P
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Dyspnea (1816); Headache (1880); Dizziness (2194); Sore Throat (2396); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2018
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.During device evaluation dust/dirt contamination in the blower unit was found.No allegation of patient harm or injury was reported.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
This mdr is being submitted as part of a batch submission of complaints that were reassessed as reportable foam degradation complaints; discovered as part of a retrospective remediation review.
Additional Manufacturer Narrative
The manufacturer previously reported received information alleging an issue related to a bipap device's sound abatement foam.B5 should have been reported as: the manufacturer received information alleging a bipap device's sound abatement foam became degraded and caused worsening seizures in 2021, nasal/throat irritation and soreness, difficulty breathing, headaches.The patient has alleged to the device being noisy.The patient did not report receiving any medical intervention.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Additional information received and section g3 has been updated to reflect new bad.Additional information received and section h6 was updated with the appropriate health effect - clinical code(s) and type of investigation, investigation findings, investigation conclusions were corrected to reflect that the manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: BIPAP S/T C SERIES DOM 30
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13673494
• Report Number: 2518422-2022-07582
• Device Sequence Number: 4659501
• Product Code: BZD
• UDI-Device Identifier: 00606959039155
• UDI-Public: 00606959039155
• 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
• Report Date (Section B): 07/29/2022

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: 1060P
• Device Catalogue Number: 1060P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2013
• 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 Age: 62 YR
• Patient Sex: Male