MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-02 for TOSHIBA KXO-100G manufactured by Toshiba Medical Systems Corporation.
[2174198]
Patient experienced depilation of the head during the placing of a head clipping coil. The user facility requested the evaluation of the device by a toshiba service engineer.
Patient Sequence No: 1, Text Type: D, B5
[9261112]
The system was evaluated by a toshiba service engineer, to include radiation dose. The system was found to be within manufacturer's specification. No system defects were noted. This report is being filed as the result of a retrospective review of complaints during an internal audit.
Patient Sequence No: 1, Text Type: N, H10
[17038910]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[17320943]
(b)(4). Additional manufacturer narrative (in addition to narrative in original submission):since the system is not equipped with the dose meter, it is calculated by the x-ray conditions. The dose calculation result for the patient with hair lost is below. Fluoroscopy pulsed fluoroscopy conditions (the typical condition in this case) /tube voltage :70kv /tube current : 50ma /pulse width : 10msec /pulse rate: 15fps / fluoroscopy cumulative time: 20min / fluoroscopy cumulative dose (on the patient's surface) : 693. 5mgyradiography radiography conditions (the typical condition in this case) /tube voltage :70kv /tube current : 400ma / pulse width: 60msec / frame rate :5fps /the number of radiography frames: 1107 /radiography total dose (on the patient's surface) : 2047. 21mgy. The total dose value is the sum of fluoroscopy cumulative dose and radiography total dose. The total dose value on the patient's surface is 2740. 71mgy.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020563-2011-00017 |
| MDR Report Key | 2233477 |
| Report Source | 05,06 |
| Date Received | 2011-09-02 |
| Date of Report | 2011-09-02 |
| Date of Event | 2011-01-22 |
| Date Mfgr Received | 2011-02-01 |
| Device Manufacturer Date | 2000-09-01 |
| Date Added to Maude | 2011-09-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. PAUL BIGGINS |
| Manufacturer Street | 2441 MICHELLE DRIVE |
| Manufacturer City | TUSTIN CA 92780 |
| Manufacturer Country | US |
| Manufacturer Postal | 92780 |
| Manufacturer Phone | 7147305000 |
| Manufacturer G1 | TOSHIBA MEDICAL SYSTEMS CORPORATION |
| Manufacturer Street | 1385 SHIMOISHIGAMI |
| Manufacturer City | OTAWARA-SHI, TOCHIGI 324-8550 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 324-8550 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOSHIBA |
| Generic Name | X-RAY GENERATOR |
| Product Code | IZO |
| Date Received | 2011-09-02 |
| Model Number | KXO-100G |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOSHIBA MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | 1385 SHIMOISHIGAMI OTAWARA-SHI, TOCHIGI 324-8550 JA 324-8550 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2011-09-02 |