MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR PRO C-FLEX+; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DS450S

Device Problem Degraded (1153)

Patient Problems Angina (1710); Dyspnea (1816); Headache (1880); Memory Loss/Impairment (1958); Dizziness (2194); Sore Throat (2396); Respiratory Tract Infection (2420); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.There was no report of patient harm/injury.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 previously received information alleging chest pain, sinus pain, throat irritation, headaches, memory loss, nose piece has particles, shortness of breath, light headedness, dizziness, particles in tubing/chamber and particles in airway from device related to a cpap device's sound abatement foam.There was no report of patient harm or injury.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 a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.In initial reports section b5 mentioned incomplete, correct b5 should be - the patient alleged chest pain, sinus pain, throat irritation, headaches, memory loss, nose piece has particles, shortness of breath, light headedness, dizziness, particles in tubing/chamber and particles in airway from device related to a cpap device's sound abatement foam.There was no report of patient harm or injury.Section a1 and h6 corrected and updated in this report.

• Brand Name: REMSTAR PRO C-FLEX+
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15206
• 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: 13194159
• MDR Text Key: 285428999
• Report Number: 2518422-2022-00452
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS450S
• Device Catalogue Number: DS450S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2010
• 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