MAUDE Adverse Event Report: RESPIRONICS, INC. PHILIPS CPAP DEVICE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	560PBT
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Codes	Dyspnea (1816); Sore Throat (2396); Respiratory Tract Infection (2420); Cough (4457)
Date of Event	10/22/2021
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 cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging hard time breathing, coughing and nasal/throat irritation or soreness.There was no report of serious 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 hard time breathing, coughing and nasal/throat irritation or soreness.Related to a cpap device's sound abatement foam.There was no report of patient harm or injury.After the final attempt to have the device and components returned for evaluation, customer declined to respond to the gfe related questions and terminated the call.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(s) d4 ans h4 were corrected and section h6 updated in this report.
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 hard time breathing, coughing and nasal/throat irritation or soreness.Related to a cpap device's sound abatement foam.There was no report of patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.During the exterior investigation, observed unknown dust/dirt contamination present on the base unit and under ui knob.During the internal investigation of base unit found unknown dust/dirt contamination throughout the device internals.Dust contamination was observed in the blower and on the impeller.Sound abatement foam did not appear to have degraded and returned to its original shape when compressed.Evidence of sound abatement foam degradation/breakdown was not observed in this device.Secondary findings: the unknown dust/dirt contamination and fibers found on the blower casing/impeller and blower box was inconsistent with degraded sound abatement foam contamination.The presence of contamination throughout the airpath suggests a source external to the device.The device's downloaded event log was reviewed by the manufacturer and found no errors.The manufacturer concludes unable to directly address the symptoms outlined in the complaint.Confirmed that there was no evidence of sound abatement foam degradation/breakdown observed in the base unit.Confirmed the presence of contamination in the airpath, likely from a source external to the device.

• Brand Name: PHILIPS CPAP DEVICE
• Common Device Name: 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 15206 ; 2673970028
• MDR Report Key: 15736100
• Report Number: 2518422-2022-91287
• Device Sequence Number: 11509086
• Product Code: BZD
• UDI-Device Identifier: 00606959042858
• UDI-Public: 00606959042858
• 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,Followup
• Report Date (Section B): 02/27/2024

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: 560PBT
• Device Catalogue Number: 560PBT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 06/26/2023; 02/19/2024
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 06/27/2023; 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2015
• 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