MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP ST30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX1030H11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problem Respiratory Insufficiency (4462)

Event Date 01/11/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to bipap device's sound abatement foam.The patient alleged having residue resolving in the machine and particles in airway from the device.Patient also alleges having trouble breathing in from the residue.There is no allegation of serious or permanent harm or injury.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

The manufacturer was initially 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 reported an allegation of an issue related to a bipap device's sound abatement foam.The patient alleged having residue resolving in the machine and particles in airway from the device.Patient also alleges having trouble breathing in from the residue.There is no allegation of serious or permanent harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.Observed an unknown contaminant on the sd module flip doors and top enclosure.An unknown dust contaminant was observed on the rear panel, bottom enclosure, blower, blower seal, and blower box.Evidence of liquid ingress was observed to the blower and blower box.A keratin-like substance was observed on the blower box outlet.Evidence of sound abatement foam degradation/breakdown was not observed.The device's downloaded event log was reviewed by the manufacturer and found no erorrs.The manufacturer concludes unable to directly address the symptoms outlined in the complaint.Confirmed no presence of degraded sound abatement foam.In this report, section d9, g3, h3, h6 has been updated or corrected.

• Brand Name: DREAMSTATION BIPAP ST30
• 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7249003460
• MDR Report Key: 13505992
• MDR Text Key: 285402065
• Report Number: 2518422-2022-03939
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

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: DSX1030H11C
• Device Catalogue Number: DSX1030H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 02/10/2022
• Supplement Dates Manufacturer Received: 11/29/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2017
• 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