MAUDE Adverse Event Report: RESPIRONICS, INC DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX500H11C

Device Problem Degraded (1153)

Patient Problem Ulcer (2274)

Event Date 12/22/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused sores in the nose.The patient did receive medical intervention and reported to have taken prescribed antibiotics.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 visualization of particles related to a cpap 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 h6 updated in this report.

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 reported an allegation related to a cpap device's sound abatement foam became degraded and caused sores in the nose.The patient did receive medical intervention and reported to have taken prescribed antibiotics.Additional information was received and added to the report.The device was returned to the manufacturer's service center on 05/02/2023 for further evaluation.The device was evaluated on 10/20/2023.There was unknown dust/dirt contamination present on all surfaces of the base unit and at the air inlet where the filter would be and at the iso port entrance.There is unknown mineral deposits visible at iso port entrance.The internal aspect of the device was inspected and unknown debris in the tracks of the ui panel was observed.There are mineral deposits present on the motor casing and within blower housing suggesting unknown liquid ingress.There is an unknown white dust contamination found on the bottom enclosure, blower box housing, blower motor, blower impeller, and rear panel o-ring.A keratin-like substance was observed around the blower box outlet.Mineral spots consistent with water ingress were found within blower box, on motor casing, and within iso port.There were no errors found.The manufacturer concludes that they could not confirm the customer's allegation and there was no visible foam degradation.Section d8, d9, h2, h3 and h6 were updated.

• Brand Name: DREAMSTATION AUTO CPAP
• 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: 13253318
• MDR Text Key: 283779649
• Report Number: 2518422-2022-00896
• Device Sequence Number: 1
• Product Code: BZD
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2023

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: DSX500H11C
• Device Catalogue Number: DSX500H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/22/2021
• Initial Date FDA Received: 01/13/2022
• Supplement Dates Manufacturer Received: 04/19/2022; 10/20/2023
• Supplement Dates FDA Received: 03/28/2023; 10/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2018
• 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
• Patient Outcome(s): Other; Required Intervention