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

Device Problem Degraded (1153)

Patient Problems Liver Damage/Dysfunction (1954); Renal Failure (2041); Cancer (3262); Dry Mouth (4485)

Event Date 02/08/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused carotid/thyroid tumors, kidney disease, dry mouth, mass in the liver, interstitial lung disease and adrenal/hepatic mass.The patient did report to receive medical intervention and had mri imaging in 2021.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 a voluntary medwatch (mw5106601) alleging an issue related to a cpap device's sound abatement foam.The patient alleged carotoid/thyroid tumors, kidney disease, dry mouth, mass in the liver, interstitial lung disease and adrenal/hepatic mass.The patient did report to receive medical intervention and had mri imaging in 2021.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.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.

• Brand Name: REMSTAR AUTO SYSTEM ONE CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13694741
• MDR Text Key: 286880990
• Report Number: 2518422-2022-09216
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 03/02/2022
• Supplement Dates FDA Received: 11/24/2023
• 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): Other; Required Intervention