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

Model Number FRX500S14

Device Problem Degraded (1153)

Patient Problems Dyspnea (1816); Pulmonary Edema (2020); Cough (4457)

Event Date 05/10/2022

Event Type  Injury  

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 alleged dyspnea, cough in device related to a cpap device's sound abatement foam.There was no report of serious 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 previously reported an allegation of an issue related to sound abatement foam.         a correction to b5 was made and should be reported as:         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 reported an allegation of an issue related to a cpap device's sound abatement foam and became degraded and caused the patient to have dyspnea, cough and pulmonary edema.The patient consulted with his general physician and the doctor prescribed x-ray of the lungs with visible pulmonary edema in response to the event.There is no customer information hence we cannot reach out to the customer and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.  the manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.Section(s) b1 and b2, has changed related to the complaint changing from the reported product problem to adverse event.Section h1 has changed to reflect a serious injury.Section h6 health effect- clinical code was corrected (codes were missed in inital mdr), section h6 type of investigation, investigation findings and investigation conclusions have been updated in this report.

• Brand Name: DREAMSTATION AUTO
• 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: 15740284
• MDR Text Key: 304290687
• Report Number: 2518422-2022-91570
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/17/2023

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: FRX500S14
• Device Catalogue Number: FRX500S14
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 12/10/2022
• Supplement Dates FDA Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2017
• 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): Life Threatening; Disability