MAUDE Adverse Event Report: SUNSET HEALTHCARE SOLUTIONS NEB100; COMPRESSOR NEBULIZER

Model Number NEB100

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The sunset compressor nebulizer, neb100, cleared for use in the u.S.[510(k) k091272], was sold by a third-party distributor in (b)(4) where the voltage is 220v.This device neb100 device is designed for the u.S.Market, with a voltage requirement of 120v.When the device was used outside of its specified voltage, the motor overheated and stopped functioning.There were no reports of any death or injury associated with the overheating.The distributor in (b)(4) has recalled the device in that market and taken remedial action to prevent risk of recurrence.The distributor has recovered all sold devices and disposed of them in compliance with local regulations.The investigation by sunset healthcare solutions supports that the incidents were caused solely by a use error.The device malfunctioned due to the improper voltage used to run the device.The neb100 device instruction manual under the caution section provide clear instructions to ensure the electrical rating for the device (i.E., 120v) corresponds to the user's main voltage and frequency before plugging in the device.Additionally, the electrical rating of 120v is clearly marked on the bottom plate of the unit.The instruction manual also cautions against using electrical adapters including extension cords.As this neb100 product is solely manufactured and marketed for the u.S.Market, which utilizes the 120v electrical rating, it was determined that.There is a remote possibility this malfunction would occur while in the u.S.

Event Description

The sunset compressor nebulizer, neb100, cleared for use in the u.S.Was sold by a third-party distributor in (b)(4) where the voltage is 220v.This device neb100 device is designed for the u.S.Market, with a voltage requirement of 120v.When the device was used outside of its specified voltage, the motor overheated and stopped functioning.

• Brand Name: NEB100
• Type of Device: COMPRESSOR NEBULIZER
• Manufacturer (Section D): SUNSET HEALTHCARE SOLUTIONS; 180 n. michigan ave; suite 2000; chicago IL 60601
• Manufacturer Contact: nazree williams ; 180 n. michigan ave; suite 2000; chicago, IL 60601 ; 3125332457
• MDR Report Key: 8286974
• MDR Text Key: 136806516
• Report Number: 3006446479-2019-00002
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00848530087326
• UDI-Public: 00848530087326
• Combination Product (y/n): N
• PMA/PMN Number: K091272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Notification
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: NEB100
• Device Catalogue Number: NEB100
• Device Lot Number: 180223
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2018
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1