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

Model Number DS150HS

Device Problems Degraded (1153); Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/14/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to 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 visualization of particles in the water tank and the device stopped pushing air through the system.The patient reports the device was working with full functionality at the beginning of first use and worked great until about a month ago.The patient started to notice foam like particles in the water about a year ago.The patient reports cleaning the device with cpap wipes, replaces the masks and tubes often.The patient uses hot water to clean parts and lets them dry, once every few weeks.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: REMSTAR
• 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: 17684036
• MDR Text Key: 322648289
• Report Number: 2518422-2023-21713
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130077
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS150HS
• Device Catalogue Number: DS150HS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2023
• Initial Date FDA Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1