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

Model Number UDSX500S11F

Device Problems Mechanical Problem (1384); Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2023

Event Type  malfunction  

Event Description

The manufacturer received information regarding a repaired dreamstation auto cpap device would not turn on, device not functioning and sparked when plugged in and device got wet.There was no report of patient harm or injury.The device has not yet been returned to the manufacturer.The device is being replaced for the user and once the faulty device is received by the manufacturer.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.

Manufacturer Narrative

H3 other text : device not returned.

Manufacturer Narrative

The manufacturer previously submitted a report regarding a repaired dreamstation auto cpap device would not turn on, device not functioning and sparked when plugged in and device got wet.There was no report of patient harm or injury.The device has not yet been returned to the manufacturer.The device is being replaced for the user and once the faulty device is received by the manufacturer.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.In the previous report event description was incorrect the correct statement will be: the manufacturer previously submitted a report regarding a repaired dreamstation auto cpap device would not turn on, device not functioning and sparked when plugged in and device got wet.There was no report of patient harm or injury.The device has not yet been returned to the manufacturer.The device is being replaced for the user and once the faulty device is received by the manufacturer, a follow up report will be submitted.

• Brand Name: REP 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: 18169659
• MDR Text Key: 328533639
• Report Number: 2518422-2023-30994
• 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

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/21/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1