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

Model Number DSX900H11

Device Problems Degraded (1153); Inaccurate Delivery (2339); Detachment of Device or Device Component (2907)

Patient Problems Unspecified Mental, Emotional or Behavioural Problem (4430); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2022

Event Type  Injury  

Manufacturer Narrative

H3 other text : not returned.

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's wife ruby beck states patient (b)(6) has alzheimer's disease.His machine is not working properly.The door on the humidifier will not stay closed, if he is sleeping and it opens in the middle of the night, they hear a flood of air.Then he is not getting the appropriate amount of pressure in his mask.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

Correction in the following fields: box b adverse event/product problem -adverse event outcomes attributed to ae -required intervention type of reported complaint -serious injury device problem code: dpr-ppi-03 material integrity problem dpr-ppi-03-05 degraded patient outcoe code grid *pao-gen-02-12 - unspecified mental, emotional or behavioural problem *health impact fda c-code - c172050 health impact grid *hi-gen-12- serious injury/illness/impairment *health impact fda c-code - c172031.

• Brand Name: DREAMSTATION BIPAP
• 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 15208 ; 4125423300
• MDR Report Key: 17793786
• MDR Text Key: 324058473
• Report Number: 2518422-2023-23908
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX900H11
• Device Catalogue Number: DSX900H11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/23/2018
• 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
• Patient Outcome(s): Required Intervention