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

Model Number BLX500S15

Device Problems Contamination (1120); Overheating of Device (1437)

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

Event Date 11/26/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device was returned to third party service center.

Event Description

The manufacturer received information in relation to a dreamstation auto cpap.There was an allegation of smell of burning and warming up after a few minutes.There was no report of serious or permanent harm or injury.During evaluation of the device at a third party service center, power cord was found to be detective, blower replacement was done because of contamination.No other problems were detected.At this time, no further investigation can be performed.If any additional information is received, a follow up 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: 18221989
• MDR Text Key: 329168854
• Report Number: 2518422-2023-32142
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: BLX500S15
• Device Catalogue Number: BLX500S15
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1