MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR HEATED HUMIDIFIER; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number 1005792

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Asthma (1726); Headache (1880); Nausea (1970); Vomiting (2144); Dizziness (2194); Respiratory Tract Infection (2420); Cancer (3262); Unspecified Respiratory Problem (4464); Unspecified Hepatic or Biliary Problem (4493); Skin Inflammation/ Irritation (4545); Nodule (4551)

Event Date 10/09/2023

Event Type  Injury  

Manufacturer Narrative

The base model was not provided by the customer and is currently unknown.H3 other text : device has not been returned to the manufacturer.

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 alleged asthma.In addition, the patient also reported eye irritation, nose irritation, skin irritation, respiratory tract irritation, dizziness, headache, nausea, vomiting, lung disease, cancer, fatty liver, nodules in lungs, inadequate blood supply in brain.Medical intervention was not specified by the patient.Due to potential litigation surrounding this case, no follow up can be performed at this time.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

Manufacturer Narrative

The manufacturer was previously 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 alleged asthma.In addition, the patient also reported eye irritation, nose irritation, skin irritation, respiratory tract irritation, dizziness, headache, nausea, vomiting, lung disease, cancer, fatty liver, nodules in lungs, inadequate blood supply in brain.Medical intervention was not specified by the patient.The complaint in this device is not related to foam degradation, so it is not part of recall.The manufacturer incorrect mention the statement in the initial report.In this report, box a, box b and box h have been updated/corrected.

• Brand Name: REMSTAR HEATED HUMIDIFIER
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19180191
• MDR Text Key: 341014900
• Report Number: 2518422-2024-22322
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012633
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1005792
• Device Catalogue Number: 1005792
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/24/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other