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

Model Number DSX900H11C

Device Problem Degraded (1153)

Patient Problems Pulmonary Edema (2020); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2023

Event Type  Injury  

Event Description

The manufacturer received information alleging an issue related to the device's sound abatement foam.There was no patient harm or injury.The manufacturer's investigation in on-going.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to sound abatement foam.This action was reported to fda per 21 cfr part 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 when wake up in the morning black stuff is stuck to eyelashes and have to pull apart water hasn't been going down does not drain no mist related to a bipap device's sound abatement.Received an additional information on 03/24/2023 related to a bipap device's sound abatement foam became degraded and caused fluid in lungs, particles are floating in water.It is unknown whether the patient received medical intervention.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.Sections b1, b2, b3, b4, h1 and h6 were updated in this report.

• Brand Name: DREAMSTATION BIPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS INC; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburg, PA 15206 ; 2673970028
• MDR Report Key: 12333393
• MDR Text Key: 266959374
• Report Number: 2518422-2021-03291
• 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,Followup
• Report Date: 07/17/2023

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: DSX900H11C
• Device Catalogue Number: DSX900H11C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 08/17/2021
• Supplement Dates Manufacturer Received: 08/16/2021; 06/26/2023
• Supplement Dates FDA Received: 09/01/2021; 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2020
• 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
• Patient Outcome(s): Other