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

Model Number DS460HBT

Device Problem Degraded (1153)

Patient Problems Asthma (1726); Pulmonary Dysfunction (2019); Unspecified Respiratory Problem (4464)

Event Date 10/12/2023

Event Type  Injury  

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.Per the legal department, the patient has alleged asthma (new or worsening) and lung disease.No other clinical information or medical intervention was specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

H3 other text : the device has not been returned to the manufacturer for analysis.

• Brand Name: REMSTARPROC-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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18638288
• MDR Text Key: 334489881
• Report Number: 2518422-2024-05721
• 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: 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: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS460HBT
• Device Catalogue Number: DS460HBT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/04/2015
• 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