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

Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Cough (4457); Unspecified Respiratory Problem (4464)
Date of Event	08/13/2021
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 philips cpap device's sound abatement foam.The patient has alleged hypersensitive mucus membranes with a lot of coughing, mucus, dry cough and also the device's foam degradation.No medical intervention was required by the patient.There was no report of serious or permanent harm or injury.The device has not yet been returned to the manufacturer for investigation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
Since no device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972, z-1973, and z-1974.H3 other text : not returned to manufacturer.
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 received information alleging an issue related to a philips cpap device's sound abatement foam.The patient has alleged hypersensitive mucus membranes with a lot of coughing, mucus, dry cough and also the device's foam degradation.No medical intervention was required by the patient.There was no report of serious or permanent harm or injury.The device has not yet been returned to the manufacturer for investigation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Udi related data quality updates only.The udi in section d4 was previously reported in the incorrect format.The udi information has been updated to the correct format.

• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18133168
• Report Number: 2518422-2023-29860
• Device Sequence Number: 12710282
• Product Code: BZD
• UDI-Device Identifier: 00606959027220
• UDI-Public: (01)00606959027220
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1974-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown