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

Model Number 1007381

Device Problem Degraded (1153)

Patient Problems Cardiac Arrest (1762); Chest Pain (1776); Headache (1880); Pain (1994); Sneezing (2251); Respiratory Tract Infection (2420); Cough (4457); Renal Impairment (4499)

Event Date 01/01/2019

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.The patient alleges sinus issues, heart attack, allergy issues, headache, cough, chest pain and decrease kidney function while using the device.Medical intervention was prescription medication.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

The manufacturer previously received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.The patient alleged sinus issues, heart attack, allergy issues, headache, cough, chest pain and decrease kidney function while using the device.Medical intervention was prescription medication.After the first attempt to have the device and components returned for evaluation, customer disconnected the call after telling their details.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 section h6 updated in this report.

• Brand Name: REMSTAR AUTO
• 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: 13827156
• MDR Text Key: 288049165
• Report Number: 2518422-2022-11199
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1007381
• Device Catalogue Number: 1007381
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening; Hospitalization; Other