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

Model Number GBX500S15

Device Problems Thermal Decomposition of Device (1071); Contamination (1120)

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

Event Date 05/13/2022

Event Type  malfunction  

Event Description

The manufacturer received a report of a thermal event to a power cord of a continuous positive airway pressure (cpap) device.There was no report of harm or injury.

Manufacturer Narrative

The manufacturer has not received the device for investigation.Despite multiple requests, no device has been returned.If further information becomes available, an additional report will be filed.The manufacturer concludes no further action is needed at this time.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to sound abatement foam.The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer previously reported an allegation of an issue related to a cpap device's sound abatement foam.The manufacturer received information alleged report of a thermal event to a power cord.There was no report of serious or permanent harm or injury.The device was returned to the manufacturer's quality product investigation laboratory for investigation.The manufacturer visually inspected internal and external part of the device and found potential dark keratin particles on the blower box outlet port, no participates were observed in the humidifier's output port, sound abatement foam degradation/breakdown was not observed in the base unit, the inside of the humidifier and dreamstation had a lot of foreign substance particles throughout and within crevices reminiscent of not cleaning the device after being exposed to water and dirt.The device's event logs were downloaded and reviewed by manufacturer.The manufacturer found no error codes.The manufacturer applied power to the device and verified airflow.Risk tag ((b)(4)) associated with this mode of failure: irrit02, infect01, fire01, shock02, shock03 and shock04.The results of this investigation do not impact the calculated risks.The manufacturer concludes there was no evidence of sound abatement foam degradation or breakdown.Corrected information was provided in section h9.Section h6 updated in this report.

Manufacturer Narrative

Corrected information was provided in d9 (previously returned to manufacturer date was incorrectly captured).

• 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 15206 ; 2673970028
• MDR Report Key: 14644937
• MDR Text Key: 293642830
• Report Number: 2518422-2022-25193
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: GBX500S15
• Device Catalogue Number: GBX500S15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Treatment: DREAMSTATION HUMIDIFIER (B)(6)
• Patient Sex: Male