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

Model Number DSX500T11C

Device Problems Degraded (1153); Use of Device Problem (1670); Device Contamination with Chemical or Other Material (2944); Insufficient Information (3190)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2019

Event Type  malfunction  

Event Description

The manufacturer became aware of an allegation of a thermal event occurring to the power supply of a continuous positive airway pressure (cpap) device.There was no patient harm or injury.The manufacturer's investigation is on-going.Upon completion of the investigation, a follow-up report will be filed.

Manufacturer Narrative

The manufacturer received the cpap and associated humidifier for investigation.There was evidence of thermal damage to the dc output connector on the power supply and the power input connector of the cpap due to water ingress to the device which caused rust and corrosion to the power connectors.The finding of water ingress to the dreamstation assembly indicates the units were moved or mishandled while there was still water in the chamber or from water being spilled when filling the chamber and the devices setting in this water.The philips respironics dreamstation systems deliver positive airway pressure therapy for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing over 30 kg (66 lbs).It is for use in the home or hospital/institutional environment.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." the power supply is designed in accordance to iec 60601 and applicable parts of iec 60950.Voltage in the cpap/humidifier device is limited to 12 v dc nominal, and current is limited by the device fuse, to minimize the potential for electrical fire.The design of the electronics mechanical's are robust enough to resist damage that would result from typical usage.This device meets ul and iec requirements for flammability.There was no patient harm or injury.The manufacturer concludes that no further action is necessary at this time.

Manufacturer Narrative

This mdr is being submitted as part of a batch submission of previously closed complaints that were reassessed as reportable foam degradation complaints; discovered as part of a retrospective remediation review.The manufacturer previously reported an allegation of a thermal event occurring to the power supply of a continuous positive airway pressure (cpap) device.There was no patient harm or injury.The manufacturer received the cpap and associated humidifier for investigation.There was evidence of thermal damage to the dc output connector on the power supply and the power input connector of the cpap due to water ingress to the device which caused rust and corrosion to the power connectors.During the evaluation, discoloration was observed of the air inlet filter which is typically due to external contaminants.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

• 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: 8591969
• MDR Text Key: 144450937
• Report Number: 2518422-2019-01015
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959025646
• UDI-Public: 00606959025646
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11C
• Device Catalogue Number: DSX500T11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Date Manufacturer Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: FDA RES 88058
• Patient Sequence Number: 1
• Treatment: (B)(4) HUMIDIFIER.; H19608125FF72 HUMIDIFIER
• Patient Sex: Female