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

Model Number DSX500T11W

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Headache (1880); Sleep Dysfunction (2517); Pulmonary Hypertension (4460); Unspecified Kidney or Urinary Problem (4503)

Event Date 10/01/2021

Event Type  malfunction  

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 hypertension.The patient was prescribed medication in response to the reported event.The patient reported using an ozone based disinfection device.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

The manufacturer was initially 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.There was no report of patient harm or injury.In initial reports section b5 mentioned incomplete, correct b5 should be - the patient alleged blood pressure, headaches, frequent urination, sleep dysfunction.There was no report of patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.An inspection of the device was completed by the manufacturer and found evidence sound abatement foam degradation which was observed in the base unit and dirt/dust found on motor casing and on the motor impellers.The device downloaded event log was reviewed by the manufacturer and found one error.The manufacturer concludes evidence of sound abatement foam degradation found within the device.Pil can confirm the presence of contamination in the airpath.Section d8, d9 and h3, h6 updated/corrected in this report.Section h6 health effect- clinical code was corrected.Sections b1, b2 has changed related to the complaint changing from the reported adverse event to a product problem.Section h1 has changed to reflect a malfunction.

• 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: 12719220
• MDR Text Key: 279005382
• Report Number: 2518422-2021-05842
• 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
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11W
• Device Catalogue Number: DSX500T11W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2020
• 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
• Patient Age: 52 YR
• Patient Sex: Female