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

Model Number CAX500H12C

Device Problem Degraded (1153)

Patient Problems Cyst(s) (1800); Dyspnea (1816); Burning Sensation (2146); Unspecified Respiratory Problem (4464); Nodule (4551)

Event Date 01/12/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused the patient to develop polyps and lung infection.The patient was hospitalized in response to the reported event.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

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 continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused the patient to develop polyps, two small nodules in right lung, cysts in right sinus and lung infection.The patient also alleged breathing problem, sinus infection and burning sensation.After the final attempt to have the device and components returned for evaluation, customer declined to respond to the gfe related questions and terminated the call.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.Sections d4 and g2 corrected in this report.Section h6 corrected and updated in this report.

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15568
• 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: 13389214
• MDR Text Key: 284968397
• Report Number: 2518422-2022-02444
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CAX500H12C
• Device Catalogue Number: CAX500H12C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2020
• 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): Hospitalization