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); Liver Damage/Dysfunction (1954); Nerve Damage (1979); Numbness (2415); Cough (4457); Unspecified Kidney or Urinary Problem (4503); Solid Tumour (4552)

Event Date 01/01/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused the patient to experience cysts on thyroid, kidney/liver damage, hemangiomas tumor on spine, nerve damage, leg numbness and lesions on left kidney.The patient did not report receiving 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 reported an allegation of an issue related to sound abatement foam.  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 continuous positive airway pressure (cpap) device's sound abatement foam.The patient alleged to experience cysts on thyroid, kidney/liver damage, hemangiomas tumor on spine, nerve damage, leg numbness, lesions on left kidney, coughing up phlegm, acid reflux and prescribed protonix, thyroid getting larger and inhibits swallowing 2 masses both benign, worsened ability to sleep, sit and lie down, seeing urologist, neurologist, and neurosurgeon, and physical therapist.The reported event of acid reflux and prescribed protonix, thyroid getting larger and inhibits swallowing 2 masses both benign, worsened ability to sleep, sit and lie down, seeing urologist, neurologist, and neurosurgeon, and physical therapist 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.There was no medical intervention required by the patient.  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. .

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 12537605
• MDR Text Key: 273525580
• Report Number: 2518422-2021-04440
• 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
• Report Date: 05/16/2023

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: 09/03/2021
• Initial Date FDA Received: 09/27/2021
• Supplement Dates Manufacturer Received: 04/04/2023
• Supplement Dates FDA Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2020
• 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
• Patient Sex: Female