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

Model Number FRX500S14

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Ulcer (2274); Speech Disorder (4415)

Event Date 03/24/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused vocal cord problems since (b)(6) 2021 and diagnosed with a vocal cord ulcer, and looses voice.The patient did receive medical intervention and reported to see a ent and had fibroscopy done on (b)(6) 2021.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.Additional information was received and section b5 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 sound abatement foam and became degraded and caused cord problems since march 2021 and diagnosed with a vocal cord ulcer, and looses voice.The patient did receive medical intervention and reported to see ent and had fibroscopy done on 05/25/2021.The reported event and its reported severity was reviewed by the manufacture's clinical expert.This event is assessed as not related to the device in this case.Based on the available information, the manufacture concludes no further action is necessary.The device has not yet returned to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.Sections b1, b2 have changed related to the complaint changing from the reported adverse event to a product problem.Section h1 has changed to reflect a malfunction.Section h6 health effect- impact code, type of investigation findings and investigation conclusions has been updated.

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 an issue related to a cpap device's sound abatement foam became degraded and caused vocal cord problems since march 2021 and diagnosed with a vocal cord ulcer, and looses voice.The patient did receive medical intervention and reported to see a ent and had fibroscopy done on (b)(6) 2021.The device was returned to the manufacturer's product investigation laboratory for investigation.During the investigation, evidence of sound abatement foam degradation or breakdown was not observed in the base unit.Dust-like and fibrous contamination and other unknown contamination was observed on and around the iso port.A white crusty type of contamination, consistent with mineral deposits, were observed on the inside of the iso port and inside the blower outlet seal.Observed a slight unknown gray contamination at the air input of the blower box at the filter area.Observed potential mineral deposits or dried liquid spots on the bottom of the blower motor and in the bottom of the blower box, indicating potential water ingress.Observed an unknown white (dust like) contaminant on the top and bottom of blower motor and on the inner rim of the bottom of the blower motor air intake.Dust-like and hair-like fibrous contamination was observed on the blower outlet seal.The device's downloaded event log was reviewed by the manufacturer and found no errors.The manufacturer concludes that unable to confirm the presence of degraded sound abatement foam.Observed evidence of potential water ingress into the blower box.Confirmed multiple contaminants, inconsistent with degraded sound abatement foam, on/in the device.There is no visible damage or functionality failures of the device, which suggests that the source of contamination was external to the device.In this report, sections d9, g3, h3, and h6 have been updated or corrected.

• 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: rosko melissa ; 6501 living place; pittsburgh, PA 15206 ; 7243512041
• MDR Report Key: 14188762
• MDR Text Key: 289894401
• Report Number: 2518422-2022-14318
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2024

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 Model Number: FRX500S14
• Device Catalogue Number: FRX500S14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 03/31/2023; 04/18/2024
• Supplement Dates FDA Received: 04/17/2023; 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2020
• 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): Required Intervention; Other