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

Model Number UDSX500S11F

Device Problems Degraded (1153); Appropriate Term/Code Not Available (3191)

Patient Problems Dyspnea (1816); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/11/2023

Event Type  Injury  

Event Description

The manufacturer received information in relation a repaired dream station cpap unit.The patient alleges experiencing tightness of chest and shortness of breath and she sometimes gets woken up in the middle of the night gasping for air while using the new replacement device.Medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

H3 other text : device not returned to the manufacturer.

Manufacturer Narrative

The manufacturer previously reported information in relation a repaired dream station cpap unit.The patient alleges experiencing tightness of chest and shortness of breath and she sometimes gets woken up in the middle of the night gasping for air while using the new replacement device.Medical intervention was not specified.On the previously submitted report, the device was coded for material degradation while at this time, there is no sufficient information for a problem code, and it is not alleged anywhere in the complaint.It is corrected in this report.Therefore, this follow-up report has an updated event description as follows: the manufacturer received information in relation to a repaired dream station cpap unit.The patient is currently using an old device and is no longer experiencing tightness of chest and shortness of breath.Also, the patient alleges pneumonia, bronchitis, and other respiratory issues.The patient reports also that she sometimes gets woken up in the middle of the night gasping for air while using the new replacement device.Additionally, the patient uses an oxygen machine.The patient reports getting prescription, but other medical intervention was not specified.The patient also provided cleaning method they use and during troubleshooting was told the correct cleaning methods.Patient provided info on the filter types/replacement frequency and was again provided the correct filter instructions during troubleshooting.The patient also provided settings they thought the device was on, which was confirmed to not be the case by the philips representative, and stated they bleed oxygen into the device without using a one-way valve.The philips representative advised to talk to medical equipment provider for correct oxygen valve.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• 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: 17969783
• MDR Text Key: 326119824
• Report Number: 2518422-2023-27357
• 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
• Type of Report: Initial,Followup

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: UDSX500S11F
• Device Catalogue Number: UDSX500S11F
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 10/19/2023
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/13/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 70 YR
• Patient Sex: Female