MAUDE Adverse Event Report | 合法醫療器材資訊網
MAUDEAdverseEventReport:BARDACCESSSYSTEMSSITE-RITE8ULTRASOUNDSYSTEM,IMAGING,PULSEDECHO,ULTRASONIC.Print;Share ...
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of the battery wont hold a charge is confirmed.The scanner shuts down prematurely when ac power is removed.The root cause of the reported issue is an internal li-ion battery failure.The device was serviced, tested and returned to the customer.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
bard site rite | 合法醫療器材資訊網
MAUDE Adverse Event Report | 合法醫療器材資訊網
MAUDE Adverse Event Report | 合法醫療器材資訊網
SITE~RITE 8 ULTRASOUND SYSTEM (USA) 9770600Y ... | 合法醫療器材資訊網
“戴麥克思” 巴德瑟瑞八超音波影像系統 | 合法醫療器材資訊網
“戴麥克思” 巴德瑟瑞八超音波影像系統“Dymax” Bard Site~Rite ... | 合法醫療器材資訊網
【“戴麥克思” 巴德瑟瑞八超音波影像系統】許可證字號:衛部醫器輸字第029296號
器材品名:“戴麥克思”巴德瑟瑞八超音波影像系統許可證字號:衛部醫器輸字第029296號註銷狀態:註銷日期:註銷理由:有效日期:2022...