MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP ST30; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX1030H11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problem Cancer (3262)

Event Date 02/08/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused lymph node cancer.The patient did not report to receive any medical intervention.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

The manufacturer previously received information alleging a cpap device's sound abatement foam became degraded and caused lymph node cancer.The patient did not report to receive any medical intervention.The device was returned to the manufacturer's product investigation laboratory for investigation.The manufacturer also received humidifier.An internal visual inspection of the device and humidifier was completed by the manufacturer and found an unknown white particulate on the iso port as well as dust like and fibrous contamination.Unknown white particulate contamination on the air inlet at the filter area.A hair like contaminant in the blower box.Several unknown red colored particulates inside the tubing connector.Unknown fibrous contamination and hair-like contamination in the humidifier enclosure.Slight fibrous and dust-like contamination on the dry box seal.Light colored in determinant contamination on the dry box.Mineral deposits in the water tank as well as what appeared to be a dark colored bio contamination in one corner of the tank.The manufacturer found evidence of sound abatement foam degradation.The device's downloaded event log was reviewed by the manufacturer and found no errors.The device was applied power and the device operated properly.The manufacturer concludes multiple contaminations of white particulate, fibrous contaminant, hair, red particles,dust, bio contamination and light colored contaminant found were external to the device and mineral deposite consistent with water tank.The manufacturer concludes evidence of sound abatement foam degradation.

• Brand Name: DREAMSTATION BIPAP ST30
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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: 13685557
• MDR Text Key: 286993308
• Report Number: 2518422-2022-09158
• 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: K092818
• 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
• Report Date: 03/02/2023

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: DSX1030H11C
• Device Catalogue Number: DSX1030H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 03/07/2022
• Supplement Dates Manufacturer Received: 02/23/2023
• Supplement Dates FDA Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2018
• 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
• Treatment: HUMIDIFIER DSXHCP (SN (B)(6))
• Patient Outcome(s): Other