AtriCure Complaint Information Form

请您根据遇到的实际情况填写此表,谢谢!
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HOSPITAL/CUSTOMER INFORMATION医疗机构/客户信息
INFORMATION 信息
Physician/User Name & Title 医生姓名&职位    ____________
Facility Name 医疗机构名称    ____________
Facility Address 医疗机构地址    ____________
Facility Contact Person 医院联系人    ____________
Facility Contact Person Phone / Email 医院联系人手机/邮箱    ____________
填空1    ____________
Is facility requesting a formal response? (Yes or No)院方需要厂家官方正式回应么?
Yes
No
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GENERAL INFORMATION 一般信息
AtriCure Rep Name 代表姓名
    ____________
AtriCure Rep Phone / Email 代表电话/邮箱
    ____________
Name of Suspect Device(s) 投诉设备名称
双极射频消融隔离钳 OLL2
双极射频消融隔离钳 EMR2
双极射频消融笔 MAX3
直线式射频消融笔 MLP1
软组织剥离器 MID1
射频消融发生器系统 ASU-230
Date of Incident Occurrence 事件发生时间
日期    ____________
Alert Date (Date when you were notified of the event) 客户通知时间
日期    ____________
Description of Incident or Event 情况说明
    ____________
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PATIENT INFORMATION 患者信息
Gender (Male or Female) 性别
Male 男
Famale 女
Age 年龄
    ____________
Weight /kg 体重/公斤
    ____________
Pre-existing conditions 已有疾病
    ____________
Current Patient Condition/Outcome 目前情况
    ____________
DEVICE INFORMATION (LIST ALL ATRICURE DEVICES USED IN INCIDENT)设备信息(列出所有在事件中使用设备)
Lot/Serial Number 序列号 Qty. 数量
OLL2 ____________ ____________
EMR2 ____________ ____________
MAX3 ____________ ____________
MLP1 ____________ ____________
MID1 ____________ ____________
ASU-230 ____________ ____________
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PROCEDURE INFORMATION 手术信息
If questions are not applicable, please enter “N/A”如果问题不适用填“N/A”
Name of Procedure 手术名称    ____________
Procedure Description: (non-patient demo, maintenance, surgical procedure, or other) 过程描述:(如无患者演示,维修,外科手术或其他)    ____________
Was patient care or outcome affected: (If yes, how?) 是否影响到患者预后?    ____________
Was the patient on the pump or off the pump? 患者是否体外循环?    ____________
Was the patient heparinized? (If yes, how much?) 患者是否肝素化?    ____________
Was surgical procedure prolonged (If yes, how long?) 手术时间是否被延长?多久?    ____________
Was a back-up method or Intervention needed? 是否应用备用解决方式 (If yes, describe) 是,描述 (If no, how was the case completed?) 不是,手术如何完成?    ____________
Did the unit display an error code or message? (If yes, list) 设备是否显示报错码或其他信息?    ____________
Did another product other than AtriCure contribute to complaint? (If yes, explain) 有对AtriCure其他产品的投诉么?    ____________
How many times has the ASU been used prior to this problem? 这个问题出现前,ASU用过多少次?    ____________
If complaint involves a clamp, how many ablations were performed prior to event? 如果是钳子的问题,事件发生前进行过多少次消融?    ____________
If complaint involves a clip, was clip placed? 如果投诉涉及夹子,是否事前已放置夹子?    ____________
Was a hand-piece being cleaned between ablations? 消融之间是否对钳子进行清理?    ____________
Does patient have thick (10mm), thin, or diseased tissue? 患者是否有厚超过10mm或很薄或病变组织?    ____________
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