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

Device Problem Degraded (1153)

Patient Problems Cancer (3262); Solid Tumour (4552)

Event Date 10/06/2021

Event Type  Injury  

Event Description

The manufacturer received voluntary medwatch (mw5105868) alleging an issue related to a continuous positive airway pressure (cpap) device.The manufacturer received information alleging neuro endocrine tumor (neoplasm) in duodenum as of 2021.End user had squamous cell carcinoma lower lip removed in 2021 and will have another hospitalization or surgery coming in 2021 or 2022.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 an issue related to a cpap device's sound abatement foam became degraded and caused neuro endocrine tumor (neoplasm) in duodenum as of 2021.End user had squamous cell carcinoma lower lip removed in 2021 and will have another hospitalization or surgery coming in 2021 or 2022.There is no customer information hence we cannot reach out to the customer and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a updated report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this follow up report will be filed.

• Brand Name: REMSTAR SYSTEM ONE
• 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: 15321925
• MDR Text Key: 298904759
• Report Number: 2518422-2022-77170
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• 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: 11/08/2023

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 08/30/2022
• Supplement Dates Manufacturer Received: 11/08/2023
• Supplement Dates FDA Received: 11/08/2023
• 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