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

Model Number CAX500T12C

Device Problems Contamination (1120); Degraded (1153)

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

Event Date 11/04/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop kidney cancer and liver issues.There is no report of the medical intervention that the patient has received at this time.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 continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop kidney cancer and liver issues.There is no report of the medical intervention that the patient has received at this time.The device was returned to the manufacturer's product investigation laboratory for investigation.During lab investigation observed dust/dirt contamination in the airpath, likely from a source external to the device.Discoloration on the flip lid seal, dry box seal.Liquid ingress was observed on the blower, blower box, p4 power connector.A contaminate consistent with keratin was observed on the blower box.The manufacturer concludes there was evidence of contamination in the device and confirmed there was no evidence of sound abatement foam.

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 particles in tubing / chamber, nasal / throat irritation or soreness, nausea, strange odor related to a cpap device's sound abatement foam.There was no report of patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.During lab investigation observed confirm that the device powers up and provides airflow using a known good power supply.Pil observed dirt/dust contamination on top and bottom enclosures, ui panel, rear panel, sd cover flip door, accessory module flip door, blower box upper cap, blower, blower outlet seal, rear panel o-ring, p4 power connector.A contaminate consistent with keratin was observed on the blower box.The manufacturer concludes there was evidence of contamination in the device and confirmed there was evidence of sound abatement foam degradation.Section d8, d9 and h6 has been updated in this report.

• 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: 12788150
• MDR Text Key: 280592654
• Report Number: 2518422-2021-06551
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959034549
• UDI-Public: 00606959034549
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CAX500T12C
• Device Catalogue Number: CAX500T12C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2017
• 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