Rossmax Swiss GmbH

Tramstrasse 16
CH - 9442 Berneck
Switzerland
Phone:  +41 71 727 11 93
Fax:  +41 71 727 11 91
E-mail: 
 
Name of authorized representatives: Morten Brunvoll
Company registration number: CH-320.4.067.787-9
Tax No.:  CHE-115.954.682
 
Bank: St. Galler Kantonalbank, Auerstrasse 2, CH-9435 Heerbrugg
Account No.: 6101.8434.2001
Swift/BIC code: KBSGCH22
IBAN-Nr.: CH77 0078 1610 1843 4200 1

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公 告

关于对国家医疗器械抽验产品检验结果送达告知书(沪)国械抽送告2017020002AB号之处理说明

国家医疗器械抽验产品检验结果送达告知书(沪)国械抽送告2017020002AB号列出我企业生产的电子血压计,规格型号AB701f,生产日期/出厂编号1705000220,在国家医疗器械抽验中经检验被发现不符合标准规定.具体为该产品之说明书前言缺失”本产品系统整体有效行的评价采用听诊法进行验证.验证结果符合YY0667-2008的要求,即平均差不超过±5mmHg,标准差不超过8mmHg.故本产品所测的血压值与听诊法的测量值等价.”对于此情况,我企业做出以下说明:
一.事情经过

2017年5月上海市市场监督管理局对我司AB701f手臂式电子血压计(批号:1705,批量504台)进行了抽样并送往中央军委后勤保障部药品仪器检验所进行检测. 2017年7月4日承检老师与我司就该产品之说明书前言缺失”本产品系统整体有效行的评价采用听诊法进行验证.验证结果符合YY0667-2008的要求,即平均差不超过±5mmHg,标准差不超过8mmHg.故本产品所测的血压值与听诊法的测量值等价.”一事进行了沟通确认.
二.原因说明

该产品说明书排版印刷过程,将前言最后一段内容遗漏

三.采取措施
1.我司立即对此批产品库存进行清点,隔离,标示.经查,库存有503台.并于2017年7月31前将库存剩余503台产品进行了返工(说明书加贴贴纸,将漏印内容贴上).
2.对该产品说明书图档进行了修增整改.
3.对我司目前上市销售的其他机型之产品说明书进行了确认未发现有类似问题.
四.风险分析
对本产品风险分析报告进行再确认, 经确认此遗漏内容仅仅是对本产品所测的血压值与听诊法的测量值等价的相关性的声明,并不涉及操作与使用,其对产品安全性及有效性并无任何影响.请广大用户放心使用.如有需完整印刷版本之说明书,可联络我司进行更新.

以上敬请了解,谢谢!

优盛医疗电子(上海)有限公司
2018年10月30日