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 Cancer (3262)

Event Date 03/18/2022

Event Type  Injury  

Event Description

A user contacted the manufacturer regarding the sound abatement foam correction/removal for their bipap device.The patient alleges to have lung cancer.There is no report of medical intervention being required.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

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 a lung cancer.The medical intervention was not specified.The device was returned to the manufacturer's product investigation laboratory for further investigation.During the investigation, the manufacturer observed a high-pitched whine sound coming from the device determined to be from the blower.There were 0 blower hours and 0 therapy hours were logged, suggesting the device data was reset prior to manufacturer receipt.No errors were logged.Dust/dirt contamination was observed throughout device enclosure, and airpath, suggesting a source external to the device.Slight black contamination at the blower seal of the blower box is consistent with the keratin contamination.The manufacturer concludes there was no evidence of sound abatement foam degradation and confirmed dust and dirt contamination throughout device enclosure, and airpath, suggesting a source external to the device.Sections d8, d9, h2, h3, and h6 were updated.

• 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 ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13980014
• MDR Text Key: 288469571
• Report Number: 2518422-2022-12377
• 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,Followup
• Report Date: 12/21/2023

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: 03/18/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 12/12/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2020
• 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
• Patient Outcome(s): Other