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Warning Text %XTableStyleMedium9PivotStyleLight16`'FSheet1l]Sheet2S_Sheet38 TN&MSD Project Risk Assessment for P11021ID Risk ItemEffectCause LikelihoodSeverity ImportanceAction to Minimize RiskOwner1(Enclosure around pump is not water proof$Electronics not compatible with LVAD"Insufficient manufacturing methods5Backup plan: move internal electronics away from pumpME2EE/ME3Battery life is too lowDevice fails prematurely Insufficient battery needs+Spec out all electronics earlier in projectEE4Device fails before patientEngineering design failure;When specifying parts make sure long lifetimes exist, test EE/CE5Software package not sufficient&Slow data transfer, calculations wrongEngineering designSpecify, model and testCE67"Overall external size is too largeInconvenient for userBudget constraints, over design8Extensive research and benchmarking current technologies8External package is not robust+Insufficient for user s needs, device fails4Engineering design, inappropriate material selectionNExtensive research and benchmarking current technologies, testing of materials9*Device is not compatible with current LVADDevice failure'Regular tests and system design reviewsCE/EE10 Exceed budgetProject discontinues+Overdesign, cost of equipment and materials1Bill of materials reviewed with customer and teamAll$Micro controller not powerful enough,No impeller levitation, low/high blood flow %Specifying unsuitable microcontroller9Testing in lab, specification of I/O and software design 0External package doesn t have sufficient airflow$External device has no heat exchange3Electronics will overheat and not function properly-Heat analysis after electronics are specified116Proper Parts are not availible or have long lead times0Project will not be finished within the timeline3Insufficient research into appropriate alternatives$Research lead times early in project'Electronics in external enclosure fail StatusCCurrent tests show it is splash resistant but not fully submersible{Current heat transfer analysis shows that interal tempeature is not indanger of reaching temperatures that will damage chipdCurrent robustness testing indcates that external package will survive fall and will not be damaged.cLead times of most components have been identified. 26-pin connector has longest lead time thus far.Current dimensions are 62 in3, 50 in3 is ideal$%No complaints thus farRP. .|/V0011[33b56Occ PK![Content_Types].xmlj0Eжr(΢Iw},-j4 wP-t#bΙ{UTU^hd}㨫)*1P' ^W0)T9<l#$yi};~@(Hu* Dנz/0ǰ $ X3aZ,D0j~3߶b~i>3\`?/[G\!-Rk.sԻ..a濭?PK!֧6 _rels/.relsj0 }Q%v/C/}(h"O = C?hv=Ʌ%[xp{۵_Pѣ<1H0ORBdJE4b$q_6LR7`0̞O,En7Lib/SeеPK!kytheme/theme/themeManager.xml M @}w7c(EbˮCAǠҟ7՛K Y, e.|,H,lxɴIsQ}#Ր ֵ+!,^$j=GW)E+& 8PK!ÄA theme/theme/theme1.xmlYOoE#F{oc'NjGuرhF[xw;23NjHH q Jĥ|@_73xM6{o~(fIyWk"޽aJCR$'Mnlu"^T$}*OIB.bQn̖kC 0>ACMȉ<&J &M5BNe tY>?#!mfKx=[Ԃu}ˆ ~umoLz^W/}ةLo;9iwk/_tV[,ac߬56YvYp1ϡAz 9ۮ7ެe ."Zk1~EȰ RӔ/x$( :7vʗsSj{"bF^x^xz?>~,ɸ7Gg_zy5^|?}V I򋧿>O~I|SQ>19D{<Ÿ8ߊaG@tOE*\ʻ/ yToN:"1Q(v; y4<$jbRa|PŻǴI Y3wJG݈8b2(<& QHT^w/B(`Z!94[Mc˴j`jG7;Q]o YC5*CocU 9 IQ/ RV+`%*;æWѼ9/#~7qZ$*cߓrUngN>%OOi Dh[BvoLJƌB6>p&>w O]>_x.eywQ,5,^<ؾt&9 ԔEЇIIqhJ#f6kAS&2D)p3ӕ5teO`jvzEOG)9cshger-# ~fu-ԙՍh&9܊- 6 AлY3hX"M$#Fz6#b.w*lyhĭɾ̮]nR3+=,)'Kak.zi X 8Ka6!_ 5[ M܆< kW Ds/Z/j@&8?&5- C⫲K3Zw1K|D!`~J0A?Uֶy&,Xg1K#[y$[BTV)bBRvVt=낕@[\׶Dž8d4~_@`rx \kp*O69mY&ԧ HE]HKN!Vj%2BƣJԊ=" u\ӵC&Y0>g4&oN)j rihr"VTU,koy#ŬjQJpRk3܎Ws;ɢ!JT~u "֠ۀW_ Nq֙4)ڬuZˋw֒TvќXHegvtm,{2Da*20V=CoOQ2'@C8D.IrG[Ȥiࠆ)d͛|?&f9>b|w##(ɇ"C *_p=ce΂aenv*Wm瓗{varAˇ$IDpKs6* ʢG0egAnlCYt֏$Ysă)2|FS` uz'Xr*󠍒F`Bi m/Ҷj9Xrmox86tFo˜ b`>ASDbƟPK! ѐ'theme/theme/_rels/themeManager.xml.relsM 0wooӺ&݈Э5 6?$Q ,.aic21h:qm@RN;d`o7gK(M&$R(.1r'JЊT8V"AȻHu}|$b{P8g/]QAsم(#L[PK-![Content_Types].xmlPK-!֧6 +_rels/.relsPK-!kytheme/theme/themeManager.xmlPK-!ÄA theme/theme/theme1.xmlPK-! ѐ' theme/theme/_rels/themeManager.xml.relsPK]    S\  dMbP?_*+%# &C&"Times New Roman,Normal"&12&A(%&C&"Times New Roman,Normal"&12Page &P&333333?'333333?(-؂-?)-؂-?M Quicken PDF Printererter 2.50d _ o,Letter<<DPCAwww.;http://;file://;mailto:;https://;ftp://"d,,333333?333333?&43U} @} I@} $@} @} I@} @} $@} $@}  @} }    h @            AAAAAAAAA B B B B C C C B B  DG EA FB FC FDG@G@!M@ DD FE F8  QK H. 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