MAUDE Adverse Event Report: RESPIRONICS, INC. SYSTEM ONE HT HUMID ASSY; VENTILATOR, NON-LIFE SUPPORTING

Model Number DS6TFLG

Device Problem Degraded (1153)

Patient Problem Dry Mouth (4485)

Event Date 11/01/2023

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 the device is not using water with the light flashing.The patient alleges they are waking up dry.There is no allegation of serious or permanent harm or injury.Medical intervention was not specified.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Manufacturer Narrative

The manufacturer previously reported information 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 the device is not using water with the light flashing.The patient alleges they are waking up dry.There is no allegation of serious or permanent harm or injury.Medical intervention was not specified.The previous report did not have the correct suspected medical device information and the correct 510k number.This report is being filed to correct this information.

• Brand Name: SYSTEM ONE HT HUMID ASSY
• Type of Device: VENTILATOR, NON-LIFE SUPPORTING
• 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: 17691818
• MDR Text Key: 322750712
• Report Number: 2518422-2023-21800
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959032132
• UDI-Public: 00606959032132
• 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,Followup
• 2 Devices were Involved in the Event: 1 2

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: DS6TFLG
• Device Catalogue Number: DS6TFLG
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 08/03/2023
• Supplement Dates FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/30/2014
• 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