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

Model Number DSX1030T11C

Device Problem Degraded (1153)

Patient Problems Stroke/CVA (1770); Dyspnea (1816); Headache (1880); Blurred Vision (2137); Dizziness (2194); Sore Throat (2396); Unspecified Heart Problem (4454); Cough (4457); Unspecified Respiratory Problem (4464)

Event Date 07/13/2021

Event Type  Injury  

Manufacturer Narrative

H3 other text : not returned to the manufacturer.

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.The manufacturer received information alleging "the unit is beeping evertime in use, alerts that the pressure is low," not enough pressure, pressure level would drop while in use, device has a service required message, randomly turns off while in use, "device would blink and then shut off," and "device would beep when turned on." the patient alleges headaches, dizziness, lightheaded, difficulty breathing/short of breath, cough, heart issues, had a stroke, nasal dryness, fuzzy vision, gagging, "stops breathing when machine cuts off," and nasal/throat irritation or soreness.The patient states "13% heart function.495 episodes of no breathing when sleep study performed" and "have been on cpap and bipap for over 30 years.Care requires device." medical intervention was going to the "er for congestive heart failure." the device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• 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: 17455521
• MDR Text Key: 320372479
• Report Number: 2518422-2023-18248
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959045606
• UDI-Public: 00606959045606
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX1030T11C
• Device Catalogue Number: DSX1030T11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/17/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male