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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES SIU ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES SIU ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 220025
Device Problem Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/02/2018
Event Type  malfunction  
Event Description
It was reported that relevant idb was installed for australia and enabled tka on the brand new unit with no issues. Switched on the unit to the error message "pfs control hardware failure (errcode
=
40000000000). " checked all physical usb connections to the corvalent pc, checked the power switch on the siu, reinstalled the application software, recalibrated the touch screen, reinstalled the implant database, enabled tka and reinstalled the language pack to no avail.
 
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Brand NameSIU
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
Manufacturer Contact
richard confer
2828 liberty ave
suite 100
pittsburgh, pa 
4126833844
MDR Report Key9993905
MDR Text Key190179671
Report Number3010266064-2020-00806
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number220025
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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