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

Model Number DSX500H11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problem Myocardial Infarction (1969)

Event Date 12/09/2021

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 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

The manufacturer was previously received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop a heart attack.There is no report of the medical intervention that the patient has received at this time.The device was returned to the manufacturer's product investigation laboratory for investigation.An internal visual inspection of the device was completed by the manufacturer.The manufacturer found evidence of grey dust-like contaminants inside port, white powder-like contaminant on pca near air inlet and sd card reader, grey dust-like contaminants and indeterminate brown particle in top of edge of front panel, white powder-like contaminant around air inlet and on top of blower box, white powder-like contaminant around air outlet o-ring of rear panel, liquid ingress on back of rear panel, hair-like object in bottom of bottom enclosure, liquid ingress on surface, white powder-like contaminant with strong indeterminant odor observed on top of and in blower and within blower box.The manufacturer found no evidence of sound abatement foam degradation/breakdown.The device was hooked up to power supply, airflow was verified and the device operated properly.The device's event logs were downloaded and reviewed.The manufacturer found no errors logged.The manufacturer concludes there was evidence of grey dust-like contaminants inside port, white powder-like contaminant on pca near air inlet and sd card reader, grey dust-like contaminants and indeterminate brown particle in top of edge of front panel, white powder-like contaminant around air inlet and on top of blower box, white powder-like contaminant around air outlet o-ring of rear panel, liquid ingress on back of rear panel, hair-like object in bottom of bottom enclosure, liquid ingress on surface, white powder-like contaminant with strong indeterminant odor observed on top of and in blower and within blower box.The manufacturer confirmed there was no evidence of sound abatement foam degradation/breakdown.Section d9, g3 and h6 has been updated 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: 13175091
• MDR Text Key: 283298018
• Report Number: 2518422-2022-00236
• 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: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• 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
• Date Manufacturer Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2020
• 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