MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION HUMIDIFIER; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)., PRODUCT CODE:BZD

Model Number DSXHCP

Device Problems Thermal Decomposition of Device (1071); Device Operates Differently Than Expected (2913)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 03/09/2018

Event Type  malfunction  

Event Description

The manufacturer was made aware of an allegation of a thermal event to a power supply for a continuous positive airway pressure (cpap) device used in conjunction with a heated humidifier.There was no report of patient harm or injury.At this time, only the serial number and part number for the heated humidifier have been provided.The manufacturer's investigation is on-going.Upon completion of the investigation, a follow up report will be filed.

Manufacturer Narrative

The manufacturer requested the device for evaluation.No product has been received to date.No further information has been provided.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 mechanicals are robust enough to resist damage that would result from typical usage.If the device is received for evaluation and a malfunction is discovered that could cause or contribute to harm or injury, a follow up report will be filed.This device meets ul and iec requirements for flammability.There has been no report of patient harm or injury.No further action is required at this time.

• Brand Name: DREAMSTATION HUMIDIFIER
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)., PRODUCT CODE:BZD
• 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: adam price ; 1001 murry ridge lane; murrysville, PA 15668 ; 7243349303
• MDR Report Key: 7439831
• MDR Text Key: 105887559
• Report Number: 2518422-2018-00806
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959022652
• UDI-Public: 00606959022652
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2018

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: Lay User/Patient
• Device Model Number: DSXHCP
• Device Catalogue Number: DSXHCP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2018
• Supplement Dates Manufacturer Received: 03/27/2018
• Supplement Dates FDA Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1