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

Model Number DSX500H11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Dyspnea (1816); Headache (1880); Myocardial Infarction (1969); Nausea (1970); Dizziness (2194); Convulsion/Seizure (4406); Cough (4457); Unspecified Respiratory Problem (4464)

Event Date 08/12/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop seizures and a heart attack.There is no report of the medical intervention that the patient has received at this time.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

In the previous follow-up report mdr 2518422-2021-05616-1, section h6, h10 was incorrectly captured, it has been corrected in this report to reflect the correct information.The device was returned to the manufacturer's product investigation laboratory for investigation.The evidence of sound abatement foam degradation/breakdown was observed in the device and was evaluated musty odor when therapy was initiated, high pitched sound during therapy, both sides of the blower box had foam that looked like they had moisture.The manufacturer found the presence of sound abatement degradation was confirmes using fitt (foan integrity test tool), unknon white,gray and black contamination(dust like) inconsistent with degraded sound abatement foam, and some potential very small hairs or fibers at the air input of the blower box, also unknown white dust-like contamination was on top of the blower motor and the motor seal.Potential mineral deposits spots on the bottom of the blower motor, indicating potential water ingress and unknown white, specs of contamination at the bottom of the blower box along with some unknown pieces of black (inconsistent with degraded sound abatement foam )and piece of pink contamination.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer.The manufacturer found no errors.The manufacturer concludes that they could confirm the customer's allegation and there is dust / dirt contamination and the presence of multiple contaminants that are not consistent with degraded sound abatement foam in the secondary findings.

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 continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop seizures and a heart attack, lungs hurting, throat hurting, severe cough, shortness of breath, dizziness, lightheadedness, headaches, nausea and low grade temperature.There is no report of the medical intervention that the patient has received at this time.The patient had experienced lungs hurting, throat hurting, severe cough, shortness of breath, dizziness, lightheadedness, headaches, nausea and low grade temperature and was missed in intial report and corrected in this report and b5 was reported as above.The device was returned to the manufacturer's product investigation laboratory for investigation.An external visual inspection of the device was completed by the manufacturer and no contamination was found.An internal visual inspection was completed by the manufacturer and found unknown contaminant on the rear panel, and inside the iso port.A small amount of an unknown dust contaminant was observed on the blower, blower seal, and the blower box.Evidence of liquid ingress to the blower was also observed.Evidence of sound abatement foam degradation/breakdown was not observed.The device's downloaded event log was reviewed by the manufacturer and found no erorrs.The manufacturer concludes the device has contamination consistent with water ingress.There was no evidence of sound abatement foam degradation.Section d8 and d9 has been updated in this report.Section h6-clinical symptoms, type of investigation, investigation findings and investigation conclusions were corrected in this report.

• Brand Name: DREAMSTATION AUTO CPAP
• 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 15206 ; 2673970028
• MDR Report Key: 12674349
• MDR Text Key: 277698450
• Report Number: 2518422-2021-05616
• 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
• Report Date: 09/06/2023

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: DSX500H11C
• Device Catalogue Number: DSX500H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 09/22/2021
• Initial Date FDA Received: 10/21/2021
• Supplement Dates Manufacturer Received: 06/14/2023; 06/14/2023
• Supplement Dates FDA Received: 08/17/2023; 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2019
• 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): Other