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

Device Problem Degraded (1153)

Patient Problems Arrhythmia (1721); Headache (1880); Sleep Dysfunction (2517); Unspecified Respiratory Problem (4464); Unspecified Eye / Vision Problem (4471)

Event Date 06/01/2022

Event Type  malfunction  

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 : device not returned to manufacturer.

Event 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 voluntary medwatch (mw5114946).The manufacturer received information alleging an issue related to a philips cpap device's sound abatement foam.The patient has alleged of waking up in the night with extreme sinus burning for hours, degradation of eyesight, extreme headaches and sleepiness and cardiac arrhythmia (premature ventricle contractions).There was no report of serious or permanent patient harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

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 voluntary medwatch (mw5114946).The manufacturer received information alleging an issue related to a philips cpap device's sound abatement foam.The patient has alleged of waking up in the night with extreme sinus burning for hours, degradation of eyesight, extreme headaches and sleepiness and cardiac arrhythmia (premature ventricle contractions).There was no report of serious or permanent patient harm or injury.No medical intervention was required by the patient.The manufacturer has previously reported this incident for initial report which needs to be corrected to initial/final report due to maximum attempts in gfe.The following additional information has been updated in this report.The complete status has been corrected to yes and section h6 has been updated.

• Brand Name: PHILIPS CPAP DEVICE.
• Type of Device: 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 15208 ; 4125423300
• MDR Report Key: 18324762
• MDR Text Key: 330484093
• Report Number: 2518422-2023-29753
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 02/23/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1