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

Device Problem Degraded (1153)

Patient Problems Fatigue (1849); Pulmonary Edema (2020); Epistaxis (4458); Nodule (4551); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging particles in tubing/chamber, particles in airway from device, device causing blood to transfer in system that are related to a cpap device's sound abatement foam.There was no report of 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 previously reported an issue related to a cpap device's sound abatement foam become degraded and seeing particles in tubing/chamber, particles in airway from device, device causing blood to transfer in the system.There was no report of patient harm or injury.The manufacturer received new information alleging hospitalization for bleeding in nose, nodule in nose, experienced weakness due to loss of blood and received silver nitrate to stop bleeding.The patient also has pulmonery edema and was on lasix iv.In this report section b1, b2, g3, h1 and h6 has been been updated / corrected.

Manufacturer Narrative

The manufacturer was previously reported an issue related to a cpap device's sound abatement foam become degraded and seeing particles in tubing/chamber, particles in airway from device, device causing blood to transfer in the system.There was no report of patient harm or injury.In this report section h6 has been updated / corrected.

Manufacturer Narrative

The manufacturer previously submitted mdr without information in sections b1 and b2.After review, it was determined that this was missed in sections b1 and b2.Corrections to previous mdr are made in this report as follows.Section b1 was updated to reflect adverse event and/or product problem.Section b2 was updated to reflect hospitalization (initial or prolonged) and other serious or important medical events.Section h1 and h6 has been updated to reflect serious injury.

• Brand Name: DREAMSTATION CPAP
• 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 15206 ; 2673970028
• MDR Report Key: 14801581
• MDR Text Key: 302018851
• Report Number: 2518422-2022-39728
• 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,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Other