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

Model Number	AH660HS
Medical Device Problem Codes	Degraded (1153); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Chest Pain (1776); Fever (1858); Headache (1880); Sore Throat (2396); Respiratory Tract Infection (2420); Cough (4457)
Date of Event	08/25/2021
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 an issue related to a cpap device's sound abatement foam.The patient has alleged sinus infections, sore throats, coughing, chest pressure, headaches, fever, nasal/throat irritation or soreness, underwent stress test.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 previously reported an issue related to bipap device's sound abatement foam.There was no report of patient harm or injury.The patient has alleged sinus infections, sore throats, coughing, chest pressure, headaches, fever, nasal/throat irritation or soreness, underwent stress test.The device was returned to the manufacturer's quality product investigation laboratory for investigation.The manufacturer visually inspected the device.Dust/dirt contamination was found under where ui knob would sit.Humidifier flip lid retention clip was broken.Humidifier bottom enclosure screws appear to be corroded or have mineral deposits.Ui knob and dry box were missing.Significant dust/dirt contamination was found on the blower impeller and on and in the sound abatement foam.The device's event logs were downloaded and reviewed by manufacturer.The manufacturer found 5 error codes.The manufacturer applied power to the device and verified airflow.The manufacturer concludes there was no evidence of sound abatement foam degradation in the base unit, but did observe excessive dust/dirt contamination in the air path, likely from a source external to the device.Sections d4 (additional device information) and h4 (device manufacturer date) were incorrectly reported in the initial report, which were correctly updated in this follow up report.Section h6 were updated in this report.

• 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: 15709110
• Report Number: 2518422-2022-90025
• Device Sequence Number: 20066598
• Product Code: BZD
• UDI-Device Identifier: 00606959005921
• UDI-Public: 00606959005921
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2023

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: AH660HS
• Device Catalogue Number: AH660HS
• 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: 08/25/2021
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2014
• 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