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

Model Number DS450S

Device Problem Degraded (1153)

Patient Problems Dyspnea (1816); Headache (1880); Dizziness (2194); Ulcer (2274); Respiratory Tract Infection (2420); Speech Disorder (4415); Unspecified Respiratory Problem (4464); Skin Inflammation/ Irritation (4545); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/20/2021

Event Type  malfunction  

Event Description

The manufacturer received a voluntary medwatch (mw5107765) alleging a continuous positive airway pressure (cpap) device cause a patient alleged dizziness,runny nose,gums were sore and bleeding,breathing issue,irritated ears, sinus infections,hourse voice,headache, skin rashes,acd reflax.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 previously received information alleging issue related to a cpap device's sound abatement foam.The patient alleged dizziness,runny nose,gums were sore and bleeding, breathing issue, irritated ears, sinus infections, hourse voice, headache, skin rashes,acd reflax.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 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.Section h6 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 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: 15511856
• MDR Text Key: 304460986
• Report Number: 2518422-2022-83993
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091319
• 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: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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 Returned to Manufacturer: 04/27/2022
• Initial Date Manufacturer Received: 10/05/2021
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 06/19/2023
• Supplement Dates FDA Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES88058
• Patient Sequence Number: 1