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

Model Number DSX500H11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Dehydration (1807); Myocardial Infarction (1969); Choking (2464); Cancer (3262)

Event Date 01/14/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused the patient to have dehydration, choking, heart attack and kidney cancer.The medical intervention that the patient received in response to the event is currently unknown.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 an issue related to a cpap device's sound abatement foam became degraded and caused dehydration, choking, heart attack and kidney cancer.The device was returned to the manufacturer's product investigation laboratory for investigation.An external and internal visual inspection of the device was completed by the manufacturer and observed dust/dirt contamination on top and bottom enclosures, ui panel, rear panel, sd cover flip door, control dial, pca, blower, blower box, blower outlet seal, rear panel o-ring, p4 power connector.An unknown contaminate was observed inside the ui panel.The keypad was partially broken but still working.Liquid ingress with mineral deposits were observed on the blower, blower box.A contaminate consistent with keratin was observed on the blower box.Pil did observe dust/dirt contamination in the airpath, likely from a source external to the device.Pil observed no evidence of degraded sound abatement foam.The device's event logs were downloaded and reviewed by manufacturer.The manufacturer found 1 error code.The manufacturer powered up the device and provides airflow.The manufacturer concludes evidence of sound abatement foam degradation/breakdown was not observed in the base unit.Section h6 health effect-clinical code missed to add in previous report so added in this report.Medical device problem code, type of investigation, investigation findings and investigation conclusions were 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: 13509725
• MDR Text Key: 285846261
• Report Number: 2518422-2022-03919
• 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: 11/30/2023

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: 01/14/2022
• Initial Date FDA Received: 02/10/2022
• Supplement Dates Manufacturer Received: 07/20/2022; 11/22/2023
• Supplement Dates FDA Received: 04/05/2023; 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2017
• 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