MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP ST30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX1030H11

Device Problems Contamination (1120); Degraded (1153); Decrease in Pressure (1490); Noise, Audible (3273)

Patient Problem Dyspnea (1816)

Event Date 12/02/2021

Event Type  malfunction  

Event Description

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.Patient alleges difficulty breathing/short of breath, device beeping and having low pressure, alarming noise.The device was returned but not yet evaluated.There was no report of serious or permanent patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

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.Patient alleges difficulty breathing/short of breath, device beeping and having low pressure, alarming noise.There was no report of serious or permanent patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for evaluation.The external aspect of the device was inspected and the manufacturer observed dust / dirt contamination on the outer surfaces, cracks, and crevices.The manufacturer found a light amount of beige dust or dust contaminant around the outlet port.The internal aspect of the device was inspected, and the manufacturer observed evidence of water ingress in the blower and blower box, suggesting the use of non-distilled water in the humidifier water chamber.The manufacturer also observed evidence of sound abatement foam degradation in the base unit.The manufacturer found 28 instances of continue error e-223 (err_low_pressure_regulation) were logged, suggesting that the device encountered an issue that led to a decrease in pressure but the device passed pressure testing.The manufacturer observed evidence of water ingress in the blower and blower box, suggesting the use of non-distilled water in the humidifier water chamber.Risk tags (er 2229075 v15) associated with this mode of failure include: irrit02, infect01, degrad04, irrit05, underp01.The results of this investigation do not impact the calculated risks.The manufacturer concludes there was evidence of sound abatement foam degradation and dust/dirt contamination, and evidence of water ingress was observed.Section d8, d9, h2, h3 were updated in this report.Section h6 has been updated.

• Brand Name: DREAMSTATION BIPAP ST30
• 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 15208 ; 4125423300
• MDR Report Key: 17884828
• MDR Text Key: 325067750
• Report Number: 2518422-2023-25568
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102465
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX1030H11
• Device Catalogue Number: DSX1030H11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2023
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1973-2021
• Patient Sequence Number: 1