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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC MULTICARE PLATINUM; STEREOTACTIC BREAST BIOPSY SYSTEM
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HOLOGIC, INC MULTICARE PLATINUM; STEREOTACTIC BREAST BIOPSY SYSTEM Back to Search Results
Model Number 8-004-0017
Device Problem Unintended System Motion (1430)
Patient Problem Not Applicable (3189)
Event Date 06/20/2018
Event Type  malfunction  
Manufacturer Narrative
As of today the investigation regarding this issue is still in-process.A follow-up will be filed as needed.
 
Event Description
It was reported that the table randomly goes up itself, without touching anything on panel.No injury was reported.A field engineer was dispatched to the site and the investigation is still underway.
 
Event Description
The field engineer checked and measured the cables from keyboard to table.All was ok.The issue has not reoccurred.
 
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Brand Name
MULTICARE PLATINUM
Type of Device
STEREOTACTIC BREAST BIOPSY SYSTEM
Manufacturer (Section D)
HOLOGIC, INC
36 & 37 apple ridge road
danbury CT 06810
Manufacturer Contact
kristin fornieri
36 & 37 apple ridge road
danbury, CT 06810
2037318491
MDR Report Key7702515
MDR Text Key114427154
Report Number1220984-2018-00121
Device Sequence Number1
Product Code IZH
Combination Product (y/n)N
Reporter Country CodeLO
PMA/PMN Number
K030666
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8-004-0017
Device Catalogue Number8-004-0017
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/20/2018
Initial Date FDA Received07/19/2018
Supplement Dates Manufacturer Received07/20/2018
Supplement Dates FDA Received07/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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