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

Model Number DSX600H11C

Device Problem Degraded (1153)

Patient Problems Asthma (1726); Chronic Obstructive Pulmonary Disease (COPD) (2237); Pulmonary Hypertension (4460); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2023

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.The manufacturer received information alleging visualization of particles in the air path.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.

Manufacturer Narrative

Not returned.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to sound abatement foam.Additional information was received and section b5 should be reported as: 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 visualization of particles in the air path.Additional information was received that the patient alleging they are suffering from from copd asthma for last half and one year and she had also pulmonary hypertension for 6 years.No medical intervention was specified by the patient.The reported event of copd asthma, pulmonary hypertension and its reported severity was reviewed by the manufacture¿s clinical expert.The manufacturer attempted to have the device and components returned for evaluation, customer could not able to provide the information about device return.If pertinent information becomes available to the manufacturer at a later date, an follow-up report will be filed.Section(s) has been corrected to reflect adverse event.Section has been corrected to reflect serious injury.Section(s) h6-clinical code and impact code have been updated in this report.

• Brand Name: DREAMSTATION BIPAP PRO
• 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: 16589482
• MDR Text Key: 311754042
• Report Number: 2518422-2023-07379
• 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: 03/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX600H11C
• Device Catalogue Number: DSX600H11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/16/2017
• 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
• Patient Outcome(s): Other