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

Model Number FRX500S14

Device Problem Contamination (1120)

Patient Problems Sneezing (2251); Respiratory Tract Infection (2420); Speech Disorder (4415); Unspecified Respiratory Problem (4464)

Event Date 07/30/2021

Event Type  malfunction  

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 alleging an issue related to a cpap device's sound abatement foam.The patient has alleged eye irritation, hoarseness, runny nose sneezing and sinusitis.There was no report of serious or permanent patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.An external visual inspection of the device was completed by the manufacturer and found no evidence of thermal of physical damage.An internal visual inspection was completed by the manufacturer.The manufacturer found dirt/dust in the blower motor.No humidifier was returned with the device.The manufacturer confirmed that the humidifier heater plate heats by using pil humidifier.The device's downloaded event log was reviewed by the manufacturer and found e-130.The manufacturer concludes no evidence of sound abatement foam degradation or breakdown.The manufacturer confirmed evidence of dust/dirt contamination in the blower motor of the device.

• 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 15208 ; 4125423300
• MDR Report Key: 16047798
• MDR Text Key: 306192116
• Report Number: 2518422-2022-103077
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Date Returned to Manufacturer: 09/10/2021
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 12/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1