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

Model Number DSX500T11

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Pulmonary Edema (2020); Heart Failure/Congestive Heart Failure (4446); Unspecified Respiratory Problem (4464)

Event Date 12/03/2021

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 a respiratory illness.The patient was hospitalized in response to the reported event.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.The manufacturer previously reported an allegation of an issue related to a cpap device's sound abatement foam became degraded and caused a patient to develop a respiratory illness.The patient was hospitalized for heart failure and pulmonary edema.The device was returned to the manufacturer's product investigation laboratory for investigation.During the investigation observed an unknown dust contaminant on the sd card and modem flip doors.An unknown contaminant was observed on the top enclosure, inside the blower box at the air inlet, on the front panel, rear panel, bottom enclosure, blower, blower seal, and blower box.A hair-like particle was observed on the blower.Evidence of liquid ingress with a contaminant consistent with mineral deposits was observed on the blower and blower box.A keratin-like substance was observed on the blower box outlet.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 no presence of degraded sound abatement foam.In this report, section d9, g3, h3, h6 has been updated or corrected.

• 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: 13092615
• MDR Text Key: 282809059
• Report Number: 2518422-2021-08669
• 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: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11
• Device Catalogue Number: DSX500T11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2017
• 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