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

Model Number DSX500T11

Device Problem Degraded (1153)

Patient Problems Ulcer (2274); Sore Throat (2396); Unspecified Respiratory Problem (4464); Unspecified Tissue Injury (4559)

Event Date 07/02/2021

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device was scrapped.

Event Description

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 nasal/throat soreness and developed ulcers while using the device.Medical intervention was not specified.The device was scrapped and cannot be returned to the manufacturer for evaluation and investigation.No other information has been received however if additional information is received a supplemental/follow up will be sent.

Manufacturer Narrative

The manufacturer was previously 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 nasal/throat soreness and developed ulcers while using the device.Medical intervention was not specified.The device was returned to the manufacturer's quality product investigation laboratory for further investigation, in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.An internal investigation was performed on the device.The manufacturer confirmed the device had no evidence of foam degradation.The manufacturer found evidence of a faulty pca.The device was scrapped.At this time, no further investigation can be performed.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 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 15208 ; 4125423300
• MDR Report Key: 17314850
• MDR Text Key: 318973475
• Report Number: 2518422-2023-15531
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11
• Device Catalogue Number: DSX500T11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1