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

Model Number DSX500H11C

Device Problem Degraded (1153)

Patient Problems Cyst(s) (1800); Cancer (3262)

Event Date 04/19/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused skin cancer, kidney cancer and has lesions/cysts on the liver.The patient did report to receive medical intervention and had right kidney removed.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously submitted mdr 2518422-2022-16972-1 with incorrect sections b1, b2, h1, h6.Corrections to previous mdr are made in this report as follows.Section b1 was corrected to adverse event and product problem.(only product problem was checked in previous mdr) section b2 was corrected to other serious or important medical events and required intervention to prevent permanent impairment/damage.(previously it was blank) section h1 was changed from malfunction to serious injury.Section h6- health effect - impact code was updated.Section d5 was not captured in the initial mdr, it has been corrected in this report.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to sound abatement foam.  additional information was received and section b5 should be reported as:   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 cpap device's sound abatement foam.The patient alleged to skin cancer, kidney cancer and has lesions/cysts on the liver.The patient did report receiving medical intervention and had right kidney removed.The reported event of "skin cancer on the top of their nose, diagnosed with kidney cancer, and has lesions/cysts on liver" and its reported severity was reviewed by the manufacture's clinical expert.This event is assessed as not related to the device in this case.Based on the available information, the manufacture concludes no further action is necessary.The patient reported to medical intervention by removal of right kidney.The device has not yet returned to the manufacturer for evaluation and at this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• 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: 14286932
• MDR Text Key: 290772593
• Report Number: 2518422-2022-16972
• 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: 06/23/2023

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?: No
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 05/05/2022
• Supplement Dates Manufacturer Received: 05/24/2023; 05/24/2023
• Supplement Dates FDA Received: 05/29/2023; 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2016
• 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