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

Model Number DS450HS

Device Problem Degraded (1153)

Patient Problems Liver Damage/Dysfunction (1954); Chronic Obstructive Pulmonary Disease (COPD) (2237); Cancer (3262)

Event Date 10/02/2023

Event Type  Injury  

Manufacturer Narrative

G1 contact office phone: (b)(6).H3 other text : device was not returned to the manufacturer.

Event Description

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 received information alleging bladder cancer, chronic obstructive pulmonary disease (copd), and cirrhosis of the liver.There was no report of medical intervention.No additional information can be requested at this time.The manufacturer was made aware of this complaint through a representative of the customer.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19176022
• MDR Text Key: 340968415
• Report Number: 2518422-2024-22166
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS450HS
• Device Catalogue Number: DS450HS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/29/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other