Device Recall ArjoHuntleigh Flowtron ACS900 의 리콜

Recall

77551

Class 2

Z-2714-2017

2017-06-14

2017-06-26

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156467

Reports of the device failure involving delivering continuous pressure to the calf garment and not deflating as intended, without triggering an alarm.

ArjoHuntleigh sent a Field Safety Notice and Customer Response form to affected customers describing the reason for the recall and the actions to be taken. The instruction to customers is to review the Field Safety Notice and complete the Customer Response Form to acknowledge receipt and understanding of the Field Safety Notice and the required actions. These actions taken are as follows: 1. Ensure that all caregivers and users of the ArjoHuntleigh Flowtron ACS900 pump are made aware of this Field Safety Notice (FSN) and all listed devices at facility are available to be upgraded to software version V2.000 during the service technician visit. 2. Complete and sign the enclosed Customer Response Form and return this form to the local ArjoHuntleigh office. Note: ArjoHuntleigh will contact the designated facility representative listed on the Customer Response Form to schedule service to upgrade the software on all listed devices at your facility, free of charge. The device may stay in use until the upgrade will be performed, on the condition that the patients limbs are monitored frequently and the garments are checked to ensure that they are correctly fitted to the patient and that deflation of the garments is occurring on a regular basis. It is also recommended that the pump LCD display is regularly checked to ensure that it shows that the garments are inflating and deflating correctly (in the limited number of complaints, the LCD display was blank). This Field Safety Notice must be distributed to those individuals who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Additionally they should maintain awareness of the notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. The letter states that if the customer has additional questions or they require assistance completing the Customer Response Form, they should contact ArjoHu