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

Model Number DSX500H11C

Device Problem Degraded (1153)

Patient Problems Dyspnea (1816); Rash (2033); Respiratory Tract Infection (2420); Eye Infections (4466); Eye Pain (4467); Unspecified Ear or Labyrinth Problem (4474)

Event Date 09/15/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.Patient alleged having sinus infection, facial rash, eye infection, eye pain, ear pain, difficulty breathing/short of breath.Patient also alleged taking antibiotics and nasal inhaler.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to sound abatement foam.Additional information was received and section b5 should be reported as: 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 cpap device's sound abatement foam.The patient alleged having sinus infection, facial rash, eye infection, eye pain, ear pain, difficulty breathing/short of breath.Patient also alleged taking antibiotics and nasal inhaler.There was no medical intervention required by the patient.The reported event and its reported severity was reviewed by the manufacture's clinical expert.This event is assessed as not related to the device in this case.Based on the available information, the manufacture concludes no further action is necessary.There was no medical intervention required by the patient.The device was returned to the manufacturer's quality product investigation laboratory for investigation.There was no mention of visual findings to the external part of the device.The internal aspect of the device was inspected.The manufacturer found 6 error codes.The manufacturer applied power to the device and verified airflow.The manufacturer concludes that they could not confirm the customer's allegation and there was no visible foam degradation & unit was scrapped due to age.Section(s) b1, b2, has changed related to the complaint changing from the reported adverse event to a product problem.Section h1 has changed to reflect a malfunction.Section h6 health effect- impact code, type of investigation findings and investigation conclusions has been updated.

• Brand Name: DREAMSTATION AUTO CPAP
• 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: 14918459
• MDR Text Key: 295269451
• Report Number: 2518422-2022-56991
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500H11C
• Device Catalogue Number: DSX500H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2017
• 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