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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 05/25/2018
Event Type  malfunction  
Event Description
It was reported that at the beginning of a procedure, the patient was positioned on the table and the tech was moving the table up to the height needed.She noticed that the table was moving back down slightly without command, and this would occur each time the position was changed.The patient was removed from the table and the procedure was cancelled.No injury related.A field engineer was dispatched to the site and it was determined that the control panel membrane switch needed to be replaced.Once this was completed the system was working as intended.
 
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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 Key7630148
MDR Text Key112467214
Report Number1220984-2018-00105
Device Sequence Number1
Product Code IZH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K030666
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Radiologic Technologist
Type of Report Initial
Report Date 05/25/2018
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 Radiologic Technologist
Device Model Number8-004-0017
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/25/2018
Initial Date FDA Received06/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2010
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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