AtriCure Complaint Information Form_历史项目_免费模板

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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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