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); Respiratory Insufficiency (4462)

Event Date 01/19/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging particles in tubing/chamber; difficulty breathing/short of breath related to the cpap device's sound abatement foam.There was no allegation of serious or permanent harm or injury.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 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 particles in tubing/chamber; difficulty breathing/short of breath related to the cpap device's sound abatement foam.There was no allegation of serious or permanent harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.An internal visual inspection was completed by the manufacturer.The manufacturer found unknown dust contaminant on the top enclosure and on the blower box cap, a small amount of an unknown dust contaminant and a piece of foreign particulate on bottom enclosure, dust contaminant on the blower, blower seal, and blower box.The manufacturer also found unknown dust contaminant d on the bottom enclosure, the dry box seal, dry box, and rear enclosure, evidence of liquid ingress on the heater plate, and the heat shield.The device's downloaded event log was reviewed by the manufacturer and found error code e-130.The humidifier was returned to the manufacturer's product investigation laboratory for evaluation.The manufacturer found evidence of black substance in the corners and along the edges humidifier water tank, dark and dust contaminant on the flip lid seal.The manufacturer concludes no evidence of sound abatement foam degradation/breakdown.The manufacturer also confirmed the presence of various contaminant and liquid ingress in the device.

• 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: 13559101
• MDR Text Key: 285825661
• Report Number: 2518422-2022-05566
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 02/10/2023
• Supplement Dates FDA Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2020
• 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
• Treatment: HUMIDIFIER DSXHCP SN- (B)(6).