MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-17 for CANON CAT-870B manufactured by Canon Medical Systems Corporation.
[131381504]
Table tilted uncommanded into c- arm of system causing damage to the internal workings of the table. The patient was on the table when this occurred, but was unhurt. It was reported by the customer that the table began tilting with the patient on the table without operation intervention. They were able to get the patient off the table without injury. However, the table continued to tilt into the c-arm causing irreparable damage to the table. A replacement table has been ordered. Please note that prior to the table tilting, a nurse pierced a heparin bag that was to be hung on the iv pole on the left side of the table. The bag ruptured saturating the tilt console and the foot of the table top with the heparin. The areas were cleaned, but soon after the event (table tilt) occurred. The table, table control powerboard and connecting cable are being returned to the manufacturer for investigation.
Patient Sequence No: 1, Text Type: N, H10
[131381505]
Table tilted uncommanded into c-arm of system causing damage to the internal workings of the table. Patient was on the table, but was unhurt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020563-2018-00003 |
| MDR Report Key | 8170451 |
| Date Received | 2018-12-17 |
| Date of Report | 2018-12-10 |
| Date of Event | 2018-11-08 |
| Date Mfgr Received | 2018-11-09 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2018-12-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CANON |
| Generic Name | CATHETERIZATION TABLE |
| Product Code | IXR |
| Date Received | 2018-12-17 |
| Model Number | CAT-870B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-12-17 |