FMI FIELD MODIFICATION INSTRUCTION FMI GE Healthcare Trier eaured data For eoch attri ita Serica Ser OnUTor Ooch DocuTneTTavON te Serce SsteM Tease oF Sena To oCaT FI ATMS. FMI Completion Certification Report NOTE: Distributors, Dealers or Third Party Service Providers ONLY. FMI #:_36149_ Consignee/Customer Name: A Street Address: ; Hyoncanelea / Nuatcaveliea {Pou City/State/Country: Country Code: Phone Number: Completion Date " Model Number} Serial Number Ma eiTa yyy Completion Status Sex gitoesasa | 2a/oi/rore [azi-compieted Sox git ogeisa | £3/o%/tor Gz-not Requred spx 207959 35a | p%/teIt SPX 21010 4FB5A | A P/OYeoLL Gix-completed ICi2-Not Required 03-Not Executed Ca Refused IDs - Location Unknown [O1-Completed 132-Not Required 1C13-Not Executed [C4 - Refused 1G - Location unknown IDi1-Completed C2-Not Required IC13-Not Executed C4 - Refused Ks - Location Unknown *Refer to FMI Completion Guide Comments:_FMI361S ay sled, PM v2.9 soft. has been installed. Vorffed with the Consignee that any PDM v2.8 or earlier software version media or any FRUs with v2.8 or earlier software versions were destroyed, deleted and removed from t Signature: printed Nome:__€¥6 Dorwinno Parez Title: 1g, Especfoltrda Dated and signed this_ £7 __day of _o@ £072 Page 13 0f 16 Dock DOC2590342 Rev. FMI36149GE Healthcare GEHC No. de ref. 36149 ACUSE DE RECIBO DE NOTIFICACION DE DISPOSITIVOS MEDICOS RESPUESTA REQUERIDA Complete este formularlo y devuélvalo a GE Healthcare de inmediato una vez recibido y en un plazo maximo de treinta di partir de la recepelén. Esto confirmard la recepcién y el entendimiento del Aviso de correccién de dispositivesmédicos. Nombre del centro clinico/nospital: Nostlol_ 22 Nvanmyd2a -€ ssoluel Domi: Nuawauelfin /Hvoncavelra (Pent Ciudad/Estado/Codigo postal/Pais: Direct de correo electronica: Numero de teléfono: Indique el nombre de la persona responsable que completé este formulari Firma: —+t Nombre en letra de molde: els 2 Susy Naeceta Pomayay Lazarn Cargo: EnfeRueen AS(STE Nad Fecha (DD/MM/AAAA): ga/0F/2 072 Devuelva el formulario completo escaneado o mediante una foto del formulario completo por correo electrénico Recall36149@ge.com) ic Si these Pane 69. Spon Pagina 4 detTemplate Name: EMI 36149 and FMI 36149 Fx Problem Found: FMI 36149 CARESCAPE PDM (Patient Data Module) - Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down. Action Taker FMI 36149 PDM v2.9 software has been installed, Verified the Active Software status updated tov2.9. Performed PDM admit/discharge cycle successfully Verified with the Consignee that any PDM v2.8 or earlier software version media or any FRUs with v2.8 or earlier software versions were destroyed, deleted, or removed from the site. The device passed all the required tests and has been returned to the customer for use. Verification Test: Verified the Active Software status updated to v2.9. Performed “PDM Module Admit/Discharge Cycle” procedure per instructions: Passed. Tested per PDM Ser Test Procedure.00C1257983 Rev 3: Passed. Returned PC to original settings per instructions. Equipment passed all required tests and has been returned to the customer fully functional [SD £3 [onl