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

Model Number FRX500S14

Device Problem Degraded (1153)

Patient Problems Chest Pain (1776); Itching Sensation (1943); Unspecified Hepatic or Biliary Problem (4493); Skin Inflammation/ Irritation (4545)

Event Date 10/04/2021

Event Type  malfunction  

Manufacturer Narrative

Patient stated that the device was installed in (b)(6) 2021.It was found in the third-party service center that the quantity blower hours were 1342.4, machine hours were 1342.4 and the device operating software version was 1.1.8.3313.H3 other text : device was evaluated by a 3rd party service center.

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 patient alleges itching on the face for several months, irritating pimples on arms, legs and lower back since mid- august.Patient also complains of chest pain when breathing in and "pain in the liver" since end of august.The device was evaluated at a third party service center.There was no problem found.The device was scrapped.

• 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: 17913061
• MDR Text Key: 325401561
• Report Number: 2518422-2023-25945
• 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

• Date FDA Received: 10/11/2023
• 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?: No
• Date Manufacturer Received: 10/04/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/02/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1