MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO BIPAP W/HUM/CELL; VENTILATORY SUPPORT SYSTEM

Model Number DSX700H11C

Device Problem Degraded (1153)

Patient Problems Hypersensitivity/Allergic reaction (1907); Sore Throat (2396); Unspecified Respiratory Problem (4464)

Event Date 11/09/2021

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 cpap device's sound abatement foam.The patient has alleged allergies, nasal/throat irritation or soreness.There was no report of permanent or serious patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

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 previously received information alleging allergies, nasal/throat irritation or soreness related to a bipap device's sound abatement foam.There was no report of patient harm or injury.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.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.Section d1 (brand name), d2 (type of device), d4 (additional device information) and h4 (device manufacturer date) was missed in the initial report, which was correctly updated in this follow up report.Section h6 updated in this report.

• Brand Name: DREAMSTATION AUTO BIPAP W/HUM/CELL
• Type of Device: VENTILATORY SUPPORT SYSTEM
• 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 15206 ; 2673970028
• MDR Report Key: 15735829
• MDR Text Key: 303339246
• Report Number: 2518422-2022-91425
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959025691
• UDI-Public: 00606959025691
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/27/2023

1 Device was Involved in the Event

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: DSX700H11C
• Device Catalogue Number: DSX700H11C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 05/26/2023
• Supplement Dates FDA Received: 05/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1