MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION2ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520T11C

Device Problem Intermittent Loss of Power (4016)

Patient Problem Dyspnea (1816)

Event Date 04/17/2023

Event Type  malfunction  

Event Description

The manufacturer became aware of an allegation that a user of a dreamstation2 advanced auto cpap was hospitalized due to his machine shutting down during the night.A service required error message was logged on the machine.The user was having difficulty breathing with shortness of breath.The device has been received by the manufacturer but has not yet been investigated.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported an allegation that a user of a dreamstation2 advanced auto cpap was hospitalized due to his machine shutting down during the night.A service required error message was logged on the machine.The user was having difficulty breathing with shortness of breath.The device was received for investigation.The device powered up without issue, provided airflow and the heater plate and heated tubing heated.Therapy hours were unusually high, suggesting the patient was running or using the device for significantly more than eight hours a day.Error logs contained 21 errors, 18 of which were reboot errors.The internal investigation found evidence of mineral deposits and contamination into the blower box, as well as dirt and dust throughout the airpath.Mineral deposits were observed on the interior of the rear panel near the humidifier seal, on the interior of the bottom enclosure and the underside of the heater plate and the heater spring.A small amount of discoloration or corrosion was observed on the underside of the pca.There was no evidence of a thermal component of pca failure observed.Water in the blower and/or the corrosion of the pca may have impacted the functionality of the blower which triggered the errors.The manufacturer can confirm the reboot errors occurred interrupting therapy, and on three separate dates were promoted by stop errors, which likely were the cause of the service required message.The likely cause of the reboot errors was due to the water ingress to the blower box from the humidifier.The user is cautioned "contact your health care professional if symptoms of sleep apnea recur.If you notice any unexplained changes in the performance of this device, if it is making unusual or harsh sounds, if it has been dropped or mishandled, if water is spilled into the enclosure, or if the enclosure is broken, disconnect the power cord and discontinue use.Contact your home care provider." if pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

Manufacturer Narrative

The manufacturer previously reported an allegation that a user of a dreamstation2 advanced auto cpap was hospitalized due to his machine shutting down during the night.A service required error message was logged on the machine.The user was having difficulty breathing with shortness of breath.The device was received for investigation.The device powered up without issue, provided airflow and the heater plate and heated tubing heated.Therapy hours were unusually high, suggesting the patient was running or using the device for significantly more than eight hours a day.Error logs contained 21 errors, 18 of which were reboot errors.The internal investigation found evidence of mineral deposits and contamination into the blower box, as well as dirt and dust throughout the airpath.Mineral deposits were observed on the interior of the rear panel near the humidifier seal, on the interior of the bottom enclosure and the underside of the heater plate and the heater spring.A small amount of discoloration or corrosion was observed on the underside of the pca.There was no evidence of a thermal component of pca failure observed.Water in the blower and/or the corrosion of the pca may have impacted the functionality of the blower which triggered the errors.The manufacturer can confirm the reboot errors occurred interrupting therapy, and on three separate dates were promoted by stop errors, which likely were the cause of the service required message.The likely cause of the reboot errors was due to the water ingress to the blower box from the humidifier.In this report, sections b1, h1, and h6 (health impact grid) has been updated.Upon further review, this event was determined to be a product problem.The user had experienced shortness of breath/difficulty breathing on (b)(6) 2023 and was hospitalized after seeking medical evaluation.The user was receiving therapy from this device in the hospital on the night of (b)(6) 2023 when the device was alleged to be shutting off on the user.

• Brand Name: DREAMSTATION2ADV 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: 16918896
• MDR Text Key: 315084082
• Report Number: 2518422-2023-11029
• 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: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520T11C
• Device Catalogue Number: DSX520T11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male