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

Model Number DSX500H11C

Device Problems Contamination (1120); Degraded (1153); Device Emits Odor (1425); Component Missing (2306); Misassembled During Installation (4049)

Patient Problems Chest Pain (1776); Headache (1880); Nausea (1970); Vomiting (2144); Sore Throat (2396); Wheezing (4463); Unspecified Respiratory Problem (4464)

Event Date 07/14/2021

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 dreamstation auto cpap device's sound abatement foam.Patient alleged experiencing nasal/throat irritation, nausea/vomiting, wheezing, chest pain, and headaches, an odor coming from device, missing accessory module flip door.There was no report of serious or permanent patient harm or injury.The device has returned to the manufacturer for investigation.Evaluation result stated that the complaint was not confirmed, and the technician confirmed no visible of foam particles.Additional findings included dust/dirt contamination on airpath, top and bottom enclosures, ui panel, rear panel, sd cover flip door, control dial, keypad, blower, blower box, blower outlet seal, p4 power connector, dc jack color insert.Liquid ingress was observed on the blower, blower box, p4 power connector.The manufacturer is submitting an initial final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this initial final report will be filed.

• Brand Name: DREAMSTATION AUTO CPAP
• 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: 17961460
• MDR Text Key: 325987251
• Report Number: 2518422-2023-27191
• Device Sequence Number: 1
• Product Code: BZD
• 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: 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: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500H11C
• Device Catalogue Number: DSX500H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Date Manufacturer Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2020
• 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
• Patient Sex: Female