Model Number ACUSON S3000 |
Device Problem
Break (1069)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 03/10/2016 |
Event Type
malfunction
|
Event Description
|
It was reported that the keyboard bezel has a large crack with a sharp edge near the dgc panel.No additional information was provided.We are in the process of collecting patient outcome information, but due to our commitment to the fda, we are filing upon discovery of the potential adverse event before we have received patient outcome information.Unfortunately, due to the aware date, this information is not readily available and we are making every effort to obtain this information.Should we receive further information in regards to this event, we will file a follow-up report.
|
|
Manufacturer Narrative
|
Original submission narrative: this issue is under investigation.A follow-up report will be submitted when the investigation results are available.Follow-up #1 narrative: this supplemental report is being submitted to provide additional event information, and provide the date new information was received.Additional information was received and it was reported that the phenomenon was noted during equipment testing/preventative maintenance.There was no study being performed so there was no patient involvement.No additional information was provided.Follow-up #2 narrative: this supplemental report is being submitted to provide the date new information was received by manufacturer and provide the type of report; provide the type of reportable event; provide the type of follow-up, and update the event problem and evaluation codes; and provide the investigational results.The device referenced in this report was not returned to siemens for investigation; however, the customer service engineer (cse) was onsite and visually saw that the bezel was cracked.The cse replaced the defective bezel.The control panel cracking was attributed to the product design.It was addressed with a design change to the plastic components of the control panel, implemented in october 2016.(b)(4).Note: the original emdr was submitted to the non-production environment.This report is to submit to the production environment.This emdr contains the initial submission, fu#1 and fu#2.
|
|
Event Description
|
As a result of a recent fda inspection, we are retrospectively reviewing complaints and associated documents for compliance to the regulations from 2015 to date.We have strengthened our mdr reporting criteria and we are reporting the attached medical device report as a follow-up to the original mdr submitted 10/05/16.Additional information was received and it was reported that the phenomenon was noted during equipment testing/preventative maintenance.There was no study being performed so there was no patient involvement.No additional information was provided.
|
|
Manufacturer Narrative
|
This supplemental report is being submitted to provide additional event information (see section b5), and provide the date new information was received (see section g4).
|
|
Manufacturer Narrative
|
This supplemental report is being submitted to provide the date new information was received by manufacturer and provide the type of report (see sections g4,g7); provide the type of reportable event; provide the type of follow-up, and update the event problem and evaluation codes (see sections h1,h2,h6); and provide the investigational results (see section h10).The device referenced in this report was not returned to siemens for investigation; however, the customer service engineer (cse) was onsite and visually saw that the bezel was cracked.The cse replaced the defective bezel.The control panel cracking was attributed to the product design.It was addressed with a design change to the plastic components of the control panel, implemented in (b)(6) 2016.Reference complaint (b)(4).
|
|
Search Alerts/Recalls
|