MAUDE Adverse Event Report: RESPIRONICS, INC DREAMSTATION BIPAP ST30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX1030H11

Device Problem Degraded (1153)

Patient Problems Pulmonary Emphysema (1832); Pneumonia (2011); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2022

Event Type  Injury  

Event Description

A user contacted the manufacturer regarding the sound abatement foam correction/removal for their bipap device.The user reported the on/off button does not always work.There was no allegation of serious or permanent harm or injury.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

The manufacturer previously reported an issue regarding the bipap device's sound abatement foam, and that there was no allegation of serious or permanent harm or injury.The manufacturer received new information that stated the patient is in the hospital for the 3rd time with pneumonia; patient has had persistent pneumonia; emphysema; enlarged heart.

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 a patient reported hospitalization for the 3rd time with pneumonia and the patient has had persistent pneumonia; emphysema; enlarged heart, related to a bipap device's sound abatemant foam.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.Section h6 has been updated.

• Brand Name: DREAMSTATION BIPAP ST30
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13889035
• MDR Text Key: 297712152
• Report Number: 2518422-2022-11754
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102465
• 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,Followup
• Report Date: 08/16/2023

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
• Device Model Number: DSX1030H11
• Device Catalogue Number: DSX1030H11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/22/2022
• Initial Date FDA Received: 03/24/2022
• Supplement Dates Manufacturer Received: 03/24/2022; 07/25/2022
• Supplement Dates FDA Received: 04/19/2022; 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2017
• 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): Hospitalization; Other