MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION 2 ADVANCED AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520H11C

Device Problem Circuit Failure (1089)

Patient Problem Sleep Dysfunction (2517)

Event Date 04/25/2024

Event Type  Injury  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Event Description

The manufacturer received information alleging the patient called in about service required error of her machine.The patient is also alleging she is having difficulties awakening without use of her device and due to that, she is afraid to go to sleep.The patient seek medical intervention by contacting dme at some point.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

In the pervious report it was reported that the manufacturer received information alleging the patient called in about service required error of her machine.The patient is also alleging she is having difficulties awakening without use of her device and due to that, she is afraid to go to sleep.The patient seek medical intervention by contacting dme at some point.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.The previous report stated in "type of reported complaint" product problem and it should have been "serious injury".This record was reported to correct this.

• Brand Name: DREAMSTATION 2 ADVANCED 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19123259
• MDR Text Key: 340464840
• Report Number: 2518422-2024-20196
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200480
• 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: DSX520H11C
• Device Catalogue Number: DSX520H11C
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/17/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female