MAUDE Adverse Event Report: RESPIRONICS, INC. PHILIPS BIPAP SYSTEM ONE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Degraded (1153)

Patient Problems Headache (1880); Dizziness (2194); Sore Throat (2396); Eye Burn (2523); Cancer (3262); Cough (4457); Unspecified Respiratory Problem (4464); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/15/2021

Event Type  Injury  

Event Description

The manufacturer received a voluntary medwatch (mw5103251-1) alleging a bilevel positive airway pressure (bipap) device's sound abatement foam became degraded and caused a patient to develop colon cancer.There is no report of the medical intervention that the patient has received at this time.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to sound abatement foam.  a correction to b5 was made and should be: 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 device.The manufacturer previously received information alleging an issue related to a bipap device's sound abatement foam.The patient alleged developing colon cancer.Patient also alleged dry, itching, watering burning eyes, dry sore throat, coughing, headaches ,dizziness, runny nose, upper airway irritation.There is no report of the medical intervention that the patient has received at this time.This notification was reviewed by the pms clinical expert due to the patient reporting that they were recently diagnosed with colon cancer.They stated that they had an mri, which found a large malignant mass in their colon and undistinguishable spots on the liver.They had an ultrasound of the liver, which found that the spots were cysts.They reported that they are scheduled for a hemi colectomy.They stated that they have been using the same bipap machine for approximately 12 years.No medical intervention/treatment or additional information was reported.Of note, the patient also reported "dry, itching, watering, burning eyes" as well as "dry sore throat, coughing, headaches, dizziness, runny nose, and upper airway irritation." no medical intervention/treatment was reported.With the information available at this time, these have been assessed as a non-serious injury.The device may have caused or contributed to the reported event.However, device sn and further clarifying clinical details such as device use and maintenance, details and timeline of events, relevant past medical history, and medical intervention information are unknown at this time, and we are currently unable to make attempts to obtain additional information due to a lack of customer contact information.There is no customer information and we cannot reach out to the customer, hence, attempt to have the device and components returned for evaluation and investigation can not be made at this time.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a 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 h6 health effect clinical codes were missed to capture in initial report and were captured in this report and other section h6 fields were updated in this report.

• Brand Name: PHILIPS BIPAP SYSTEM ONE
• 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 15206 ; 2673970028
• MDR Report Key: 13205326
• MDR Text Key: 283499230
• Report Number: 2518422-2022-00591
• 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
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Other