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Parks did in fact switch to a new style connector starting October 1 st . Any new units or cuffs that are ordered will come with the new fitting. Parks will no longer supply the Luer fitting. 



This issue is not exclusive to Parks alone, the Luer fitting has been in use since the late 1800’s and it is used in thousands of medical applications and products. In our research, we discovered that there have been multiple documented cases where accidental misconnections of air tubes, feeding tubes, IV tubes etc. utilizing Luer fittings has caused serious injury and death. To the best of our knowledge, none of these incidents have involved a PARKS unit. 



We also discovered in our research that there is currently an International Organization for Standards (ISO) Commission charged with evaluating the issues of misconnected Luer fitting and recommending a solution to prevent its occurrence. While the commission has not released its final recommendations, it appears that they have settled on a new type of fitting that is to be used only for air and that cannot be accidentally connected to fittings designated for IV’s, feeding tubes, etc. More information regarding the development of the new standard can be found at: 



http://www.aami.org/publications/BIT/2011/2011ND.cover.pdf 



Due to the unknown time frame of when the standard will be complete, we decided not to wait for the final recommendations. We started using the SMC fitting that meets the requirements that they are proposing. Some manufactures of blood pressure monitoring equipment also utilize this fitting. Below please find the letter that was sent out to our customers. 




Please feel free to call your sales representative with any questions at 888-503-1177 or the factory direct at 800-547-6427. 





Thank you, 

Nicole McCombie 

Sales Representative, Parks Medical Electronics Inc. 





September 10 2012 

IMPORTANT SAFETY ISSUE- SERIOUS HEALTH CONSEQUENCE 



Parks Medical Electronics, Inc. was made aware of an incident where a customer inadvertently connected an air supply tube from their PARKS PVR unit to an IV in the patient’s arm instead of into the blood pressure cuff. Fortunately, in this incident, there was no ill effect on the patient. 




In our research, we discovered that there have been multiple documented cases where accidental misconnections of air tubes, feeding tubes, IV tubes etc. utilizing Luer fittings has caused serious injury and death. To the best of our knowledge, none of these incidents have involved a PARKS unit. 




We are currently in the process of ordering parts and assembling kits to offer our customers who wish to switch over to a new style fitting that would not be compatible with other luer fittings. The kits will be provided to our customers at no cost. As customers order new cuffs and/or hose sets, these items will 

have the new luer fittings. There will be no choice but to also update all of your fittings. Installation instructions will be included with the kit. 




On October 1st, 2012 Parks Medical Electronics, inc will start sending out kits. All devices, cuffs and hose kits will be shipped with the new fittings. 




If your Parks device includes a Multi Port Inflator, order LUER UPGRADE KIT WITH MPI 

If your Parks device does not have a Multi Port Inflator, order LUER UPGRADE KIT WITHOUT MPI 




While waiting for your kit or its installation, please use extreme caution when hooking up the air supply tubes to the cuff’s Luer fittings. 




Affected models include *2100-SX, 3000 series, 2017, 2016, 2015, 2014, 1059, 1059-A, *1059-C, *1058-C, 4000 series, 1100 series, 1060 series, 1080 series, 234 and 246. * = current production model 




To help us confirm that we have reached all of our customers, please respond back via e-mail, telephone or fax. Please include: 




Unit type:________________________, Unit Serial Number(s):_______________________________________ 

Contact Name:_____________________________, E-Mail :___________________________________ 

Facility Name:____________________________________________________________________________ 

Facility Address (please include department): 

___________________________________________________________________________________ 




Parks Medical Electronics, Inc requests that you retain a copy of this letter with the Parks machine to remind users of the issue. 




For ordering your kit, please call 800-547-6427 option 0. For responses, questions or concerns please contact us at: 888-356-9522 (Phone), 503-591-9753 (Fax) or [log in to unmask] . We will be happy to assist you. 



Thank You 
----- Original Message -----
From: "Lisa Mekenas" <[log in to unmask]> 
To: [log in to unmask] 
Sent: Friday, October 19, 2012 10:01:07 AM 
Subject: Parks Flo Lab 

Just found out that Parks is changing their connectors on the machines and cuffs. Apparently there has been an issue with IV's getting connected to the inflators so the FDA has asked the connectors to be modified. I ordered some new bladders and got these crazy connectors on them. Parks' has a form you fill out and they will send you the kit to modify you machine and other cuffs with locking connectors. This started OCT 1st. 
I have heard some stuff about techs recently and lack of knowledge, but this really takes the cake. Another example of what some schools are putting out or OTJ training going on. 
I recommend emailing them your machine serial number and type, be sure and let them know if you have an automatic inflator or MPI. They are probably going to be pretty busy getting these its out. Their customer service has been pretty outstanding recently. 
Lisa 


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