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

Model Number DS460TS

Device Problem Degraded (1153)

Patient Problems Asthma (1726); Headache (1880); Dizziness (2194); Unspecified Respiratory Problem (4464); Solid Tumour (4552)

Event Date 08/30/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : device 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 eye irritation, respiratory tract irritation, dizziness, headache, asthma, brain tumor.No medical intervention was specified by the patient.  the device has not yet been returned to the manufacturer for evaluation.  at this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

Manufacturer Narrative

In previous report, reported as product problem and adverse event.In this report correction is done, report as serious injury.Now b2 and h1 section is updated/corrected.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.H6 updated/corrected.

• 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 17805455
• MDR Text Key: 324111783
• Report Number: 2518422-2023-24264
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS460TS
• Device Catalogue Number: DS460TS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/25/2013
• 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