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

Model Number FRX500S14

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Discomfort (2330); Respiratory Tract Infection (2420); Eye Burn (2523)

Event Date 07/01/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient alleges sinusitis and required steroid prescription.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Event Description

The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient alleges sinusitis and required steroid prescription.This issue was reported to the fda per 21 cfr 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 an issue related to a cpap device's sound abatement foam.The patient alleged experiencing sinusitis, burning eyes, and throat discomfort while using the device.And required steroid prescription.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.Observed dust/dirt contamination on top and bottom enclosures, ui panel, rear panel, sd cover flip door, accessory module flip door, control dial, keypad, blower, blower box, blower grommets, blower outlet seal, p4 power connector.An unknown contaminate was observed inside the ui panel.A contaminate consistent with keratin was observed on the blower box.The device's downloaded event log was reviewed by the manufacturer and found no errors.The manufacturer concludes that unable to directly address the symptoms outlined in the complaint.Observe dust/dirt contamination in the airpath, likely from a source external to the device.Observed no evidence of degraded sound abatement foam.Section h6 health effects - clinical code was missed to capture in the previous report.It has been updated or corrected in this report.  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: 13581386
• MDR Text Key: 286275654
• Report Number: 2518422-2022-06932
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,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 Operator: Lay User/Patient
• Device Model Number: FRX500S14
• Device Catalogue Number: FRX500S14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 02/18/2022
• Initial Date FDA Received: 02/22/2022
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2018
• 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
• Patient Age: 70 YR
• Patient Sex: Male