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

Model Number DSX400H11C

Device Problem Degraded (1153)

Patient Problems Arrhythmia (1721); Bacterial Infection (1735); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Convulsion/Seizure (4406); Unspecified Immune System Problem (4435); Unspecified Heart Problem (4454); Wheezing (4463); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2023

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

The manufacturer previously reported information 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 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.Additional information received from the patient alleging heart issue, difficulty breathing, gasping, tuberculosis, and immune system issue.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to sound abatement foam.Correction 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 patient alleging visualization of particles in the air path, heart issue, difficulty breathing, gasping, tuberculosis, and immune system issue,hypertension,heart arrhythmia while also suffering from major vitamin d deficiency, sleep deprivation, joint, skeletal, and muscle pain; as well as neurological issues causing him to have seizures.The reported event of alleges heart issues and its reported severity was reviewed by the manufacture¿s clinical expert.This event is assessed as serious injury.There was no medical intervention required by the patient.The device has not yet returned to the manufacturer for evaluation.A follow-up report will be submitted when the manufacturer's investigation is complete.Section(s) b1, b2, has changed related to the complaint changing from the reported product problem to adverse event.Section h1 has changed to reflect a serious injury.Section h6 health effect- impact code has been updated.

• Brand Name: DREAMSTATION CPAP 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: 16661113
• MDR Text Key: 312494371
• Report Number: 2518422-2023-08020
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX400H11C
• Device Catalogue Number: DSX400H11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2020
• 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