MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-12 for CANON INFX-8000C/UD manufactured by Canon Medical Systems Corporation.
[139819804]
A touch sensor detects a contact when a load exceeds a certain threshold. It is considered that the touch sensor did not detect a contact because the contact force was lower than its threshold. This is the device specification. The following measures are implemented and performed so that touch sensors works as intended: the system has a function that detects failure for touch sensors. It has a fail-safe design and is configured to detect faults. So, when the fail-safe function operates, a system error will generate. Detector movements are slowed down around a patient by an interference prevention function. Touch sensors are inspected to work correctly when they are shipped, and once again once they are installed at the site. Customers need to perform pre-operational checks when they start a study everyday. This is noted in the operation manual. The following contents described in the operation manual will be explained once again to the customer: pre-operational check to confirm that touch sensors work safely and as intended. To be mindul that the touch sensor may push against a patient. We judge that no further action beyond what is specified in this summary is needed. [medwatch report mw5081940].
Patient Sequence No: 1, Text Type: N, H10
[139819805]
From the original medwatch report submitted by the facility: "female patient had been found to have had an enlarging lesion in the right posterolateral portion of the right lobe of the liver. This lesion underwent biopsy. On standing the patient up, she became orthostatic and tachycardic and there was concern about post-biopsy bleeding. The patient went for a stat cta where there was seen to be some extravasation. She then went for a stat arterial embolization. During an interventional radiology procedure, the fpd sensor in the interventional suite lowered down and touched the patient's abdomen. Normally, upon touching the patient, the fpd sensor raises up and prevents itself from touching the patient. This day, the sensor did not work and the sensor stayed against the patient, causing her some pain. The fpd sensor was immediately lifted off of the patient by the radiology technician standing next to her. The third party maintenance company was called, and the fpd sensor was replaced". Please note that the customer mistakenly noted the fpd sensor as the image intensifier. This has been corrected in the above report for accuracy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020563-2019-00001 |
| MDR Report Key | 8414464 |
| Date Received | 2019-03-12 |
| Date of Report | 2019-03-12 |
| Date of Event | 2018-10-22 |
| Date Facility Aware | 2018-12-27 |
| Report Date | 2018-12-04 |
| Date Reported to FDA | 2018-12-04 |
| Date Reported to Mfgr | 2018-12-28 |
| Date Mfgr Received | 2018-12-27 |
| Device Manufacturer Date | 2009-10-01 |
| Date Added to Maude | 2019-03-12 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | 2441 MICHELLE DRIVE |
| Manufacturer City | TUSTIN CA 92780 |
| Manufacturer Country | US |
| Manufacturer Postal | 92780 |
| Manufacturer G1 | CANON 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CANON |
| Generic Name | INFINIX VC-I FD VASCULAR SYSTEM |
| Product Code | JAA |
| Date Received | 2019-03-12 |
| Model Number | INFX-8000C/UD |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 10 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CANON MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | 1385 SHIMOISHIGAMI OTAWARA-SHI, TOCHIGI, 324-8550 JA 324-8550 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-12 |