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

Device Problem Degraded (1153)

Patient Problems Dyspnea (1816); Fatigue (1849); Hemoptysis (1887); Renal Failure (2041); Weight Changes (2607); Cough (4457); Dry Mouth (4485)

Event Date 10/12/2022

Event Type  Death  

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 information alleging an issue related to a bipap device's sound abatement foam became degraded and caused dry mouth/throat, fatigue, kidney failure, cough, coughing up blood, shortness of breath, weight loss that resulted in death.The patient's family member did report to receive the patient to receive medical intervention which was hospitalization, x-rays, ct scans and ultrasounds.The patient's family member reported this to the fda on vmw #mw5112464.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 information alleging an issue related to a bipap device's sound abatement foam became degraded and caused dry mouth/throat, fatigue, kidney failure, cough, coughing up blood, shortness of breath, weight loss that resulted in death.The patient's family member did report to receive the patient medical intervention which was hospitalization, x-rays, ct scans and ultrasounds.The patient's family member reported this to the fda on vmw #mw5112464.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this updated report will be filed.Section h6 updated in this report.

• Brand Name: PHILIPS DREAMSTATION BIPAP
• 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: 15754153
• MDR Text Key: 303258257
• Report Number: 2518422-2022-91066
• 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: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Death; Other; Hospitalization