MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP ST30; VENTILATORY SUPPORT SYSTEM

Model Number DSX1030H11C

Device Problem Degraded (1153)

Patient Problem Dry Mouth (4485)

Event Date 01/18/2022

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 bipap device's sound abatement foam.Patient alleged having dry mouth.The device was returned and manufacturer could not confirm customer complaint and there were no problem found during device evaluation.There was no report of serious or permanent patient harm or injury.

• Brand Name: DREAMSTATION BIPAP ST30
• 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 15208 ; 4125423300
• MDR Report Key: 17470997
• MDR Text Key: 320520084
• Report Number: 2518422-2023-18572
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959045590
• UDI-Public: 00606959045590
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102465
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX1030H11C
• Device Catalogue Number: DSX1030H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2023
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2017
• 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