MAUDE Adverse Event Report: RESPIRONICS, INC REMSTAR PRO C-FLEX+; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 460P

Device Problems Contamination (1120); Degraded (1153); Contamination of Device Ingredient or Reagent (2901)

Patient Problems Dyspnea (1816); Cancer (3262); Cough (4457)

Event Date 08/27/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient alleged of having difficulty breathing/short of breath, cough, ovarian and myeloma cancer.The patient also having a chest x-ray.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.Section h6 medical device problem code was incorrectly captured in follow up report (2518422-2022-58195-1), now its corrected and updated in this report.

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 reported allegation of an issue related to sound abatement foam and became degraded and caused the patient to have difficulty breathing/short of breath, cough, ovarian and myeloma cancer.The patient also having a chest x-ray.The medical intervention that the patient received in response to the event is currently unknown.The device was returned to the manufacturer's quality product investigation laboratory for investigation.The manufacturer visually inspected the external part of the device and found signs of contamination on the outside of the device.The contamination was on the screen of the device.The manufacturer visually inspected the device internally and found no signs of contamination on the inside of the device.The device's event logs were downloaded and reviewed by manufacturer.The manufacturer found no error codes.The manufacturer applied power to the device and verified airflow.The manufacturer concludes there was no evidence of sound abatement foam degradation/breakdown, but found signs of contamination on the screen of the device.Section h6 (medical device code, type of investigation, investigation findings, investigation conclusions) were updated in this report.

• Brand Name: REMSTAR PRO C-FLEX+
• 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: 14935658
• MDR Text Key: 295363893
• Report Number: 2518422-2022-58195
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959030107
• UDI-Public: 00606959030107
• 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: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 460P
• Device Catalogue Number: 460P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2012
• 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