MAUDE Adverse Event Report: RESPIRONICS, INC. SYSTEM ONE 60 SERIES; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DS6H

Device Problem Degraded (1153)

Patient Problems Headache (1880); Dizziness (2194); Unspecified Respiratory Problem (4464); Unspecified Kidney or Urinary Problem (4503); Skin Inflammation/ Irritation (4545)

Event Date 08/30/2023

Event Type  Injury  

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 nose irritation, respiratory tract irritation, dizziness, headaches, and kidney disease/toxicity.The manufacturer was made aware of this complaint through a representative of the customer.No other information has been received, however, if additional information is received a supplemental/follow up will be sent.

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 nose irritation, respiratory tract irritation, dizziness, headaches, and kidney disease/toxicity.The manufacturer was made aware of this complaint through a representative of the customer.In the previous report, the device information reported was the device accessory information.The base device information is unknown and three attempts to acquire more information and the device return were unsuccessful.The device information has been corrected to a generic philip's cpap device.

• Brand Name: SYSTEM ONE 60 SERIES
• Type of Device: VENTILATOR, CONTINUOUS, 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: 17833452
• MDR Text Key: 324460681
• Report Number: 2518422-2023-24774
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959032149
• UDI-Public: 00606959032149
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090539
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DS6H
• Device Catalogue Number: DS6H
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 08/30/2023
• Supplement Dates FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1973-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening