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

Model Number GBX500S15

Device Problem Device Emits Odor (1425)

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

Event Date 10/20/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not yet evaluated.

Event Description

The manufacturer received an information from user alleging the dream station auto cpap caused burning smell and stated clearly dangerous to use.There is no report of serious injury or harm.The device has returned to the manufacturer.The manufacturer's investigation is ongoing.Upon completion of the investigation, a follow up report will be filed.

Manufacturer Narrative

In the previous mdr 2518422-2023-28755 the manufacturer reported allegation related to the dream station auto cpap device that caused burning smell.After the review of the complaint filling this report to indicate that the cause burning smell is not reportable.The below correction were made to reflect this is a not reportable event.Section b1, h1 were reported as product problem and malfunction and those are not required in this report.The mdr 2518422-2023-28755 is not reportable.Please discard the initial mdr.

• 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: 18063625
• MDR Text Key: 327244109
• Report Number: 2518422-2023-28755
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• 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: 11/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: GBX500S15
• Device Catalogue Number: GBX500S15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2023
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1