FDA Adverse Event
Malfunction
Summary report: N
MICROSELECTRON_HDR (CLASSIC)
MDR report key: 218957
·
Received April 8, 1999
Report
- Report Number
- 1121753-1999-00004
- Event Type
- Malfunction
- Date Received
- April 8, 1999
- Date of Event
- March 11, 1999
- Report Date
- March 29, 1999
- Manufacturer
- NUCLETRON BV
- Product Code
- JAQ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING A HIGH DOSE RATE TREATMENT, THE TREATMENT CONTROL UNIT OF THE MHDR STOPPED UPDATING THE PRINTER AND THE "LCD". THE LOCKUP OCCURRED WHILE THE SOURCE WAS DWELLING IN THE LAST DWELL POSITION TO BE TREATED. THE PHYSICIST NOTED THAT THE TREATMENT TIME HAD EXCEEDED 50 SECONDS AND TEH CONSOLE DID NOT INDICATE TREATMENT HAD ENDED. THE SOURCE WAS NOTED TO HAVE RETRACTED AFTER A SHORT PERIOD OF TIME BECAUSE THE PRIME ALERT CEASED SOUNDING. A NECLETRON FIELD SERVICE ENGINEER WENT ON SITE ON THE MORNING ON MARCH 12 AND USING THE HAND HELD TERMINAL DETERMINED THAT TREATMENT OF THE LAST DWELL POSITION WAS COMPLETED IN ITS ENTIRETY AS PROGRAMMED. THE PRESCRIBED DOSE WAS DELIVERED TO THE PROGRAMMED AND INTENDED POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROSELECTRON_HDR (CLASSIC) | REMOTE CONTROLLED RADIONUCLIDE APPLICATOR SYSTEM | JAQ | NUCLETRON BV | M/HDR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |