MAUDE Adverse Event Report: RESPIRONICS INC DREAMSTATION AUTO CPAP W/HUM/CELL, DOM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX500H11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Dyspnea (1816); Fever (1858); Sore Throat (2396); Respiratory Tract Infection (2420); Sleep Dysfunction (2517); Cough (4457); Unspecified Respiratory Problem (4464)

Event Date 08/17/2021

Event Type  malfunction  

Event Description

The manufacturer received a voluntary medwatch (mw5102695) alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop chest congestion.The patient was prescribed medication in response to the reported event.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

The manufacturer previously received a voluntary medwatch (mw5102695) alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop chest congestion.The patient was prescribed medication in response to the reported event.In the initial report section b5 was not updated, the correct b5 should be - the manufacturer received voluntary medwatch (mw5102695).The patient has alleged hard cough, shortness of breath, congestion in chest, fever, throat problem, lung infection, sleep problem, phelgm.There was no report of serious or permanent patient harm or injury.In the initial report, section b3 date was incorrectly and h10 section was marked incorrectly.The device was returned to the manufacturer's product investigation laboratory for investigation.An internal visual inspection was completed by the manufacturer.The manufacturer found evidence of contamination through-out; white powdery substance indicative of talc/dust.The manufacturer found no evidence of sound abatement foam degradation.The device's downloaded event log was reviewed by the manufacturer and found no error logged.The manufacturer concludes the contaminates found were consistent with contamination through out the device; white powdery substance indicative of talc/dust.The manufacturer confirmed there was no evidence of sound abatement foam degradation.Section b1,b2,b7,b3,d9,g3,h1,h6,h10 has been updated/corrected.

• Brand Name: DREAMSTATION AUTO CPAP W/HUM/CELL, DOM
• 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: 12467927
• MDR Text Key: 271280194
• Report Number: 2518422-2021-03974
• 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: 02/01/2023

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: 08/16/2021
• Initial Date FDA Received: 09/14/2021
• Supplement Dates Manufacturer Received: 01/19/2023
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2017
• 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