MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX900T11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2022

Event Type  malfunction  

Event Description

A user contacted the manufacturer regarding the sound abatement foam correction/removal related to a bipap device.The user reported the machine has overheated several times, not working properly, device will not turn on/device not functioning, device/power cord or supply too hot to touch.There was no report of patient 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 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 an issue related to a bipap device's sound abatement foam.Patient alleged the machine has overheated several times, not working properly, device will not turn on/device not functioning, device/power cord or supply too hot to touch.There was no report of patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.During the investigation ,because of a complaint regarding the base unit overheating and the power supply being too hot to touch, additional testing was performed.The results showed the device base maximum temperature and the power supply maximum temperature were within spec.During the exterior investigation, observed unknown dust or irt contamination present on all surfaces of the base unit.Found unknown dust contaminants present at the air inlet where the filter would be and at the iso port entrance.During the interior investigation, observed unknown debris in the tracks of the ui panel.Found mineral deposits present on the motor casing and within the blower box housing, suggesting unknown liquid ingress.There is an unknown white dust contamination found on the bottom enclosure, blower box housing, blower motor, blower impeller, and rear panel o-ring.Evidence of sound abatement foam degradation or breakdown was not observed in the base unit.In secondary findings, a keratin-like substance was observed around the blower box outlet.Observed that the unknown dust or dirt contamination and fibers found on the blower casing, impeller, and blower box were inconsistent with degraded sound abatement foam contamination.The presence of contamination throughout the airway suggests a source external to the device.Observed mineral spots consistent with water ingress were found within the blower box, motor casing, bottom enclosure, and blower box housing.The device's downloaded event log was reviewed by the manufacturer and found one errors.The manufacturer concludes that, unable to directly address the symptoms outlined in the complaint.Confirmed that there was no evidence of sound abatement foam degradation or breakdown observed in the base unit.Confirmed the presence of contamination in the airway.In this report, section d9, g3, h3, h6 has been updated.

• Brand Name: DREAMSTATION BIPAP AUTOSV
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 13773432
• MDR Text Key: 295156096
• Report Number: 2518422-2022-10688
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090539
• 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: 03/13/2024

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: DSX900T11C
• Device Catalogue Number: DSX900T11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2018
• 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