MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-09-30 for SHIMADZU HS-10A manufactured by Shimadzu Medical Systems.
[15448405]
Hospital advised distributor on 9/2/94 that the table had tilted to 90 degrees by itself. Anesthesiologist was injured trying to keep pt from falling when table tilted. Technician involved in the incident reported to coporation's senior imaging specialist that the table would not move laterally using the footswitch. During removal of the pt from the table, it began tilting and would not respond to the footswitch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 38771-1994-09001 |
| MDR Report Key | 19549 |
| Date Received | 1994-09-30 |
| Date of Report | 1994-09-09 |
| Date of Event | 1994-09-02 |
| Date Facility Aware | 1994-09-02 |
| Report Date | 1994-09-09 |
| Date Added to Maude | 1995-02-09 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHIMADZU HS-10A |
| Generic Name | UROLOGICAL X-RAY SYSTEM |
| Product Code | IXK |
| Date Received | 1994-09-30 |
| Model Number | HS-10A |
| Catalog Number | HS-10A |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 24 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 19454 |
| Manufacturer | SHIMADZU MEDICAL SYSTEMS |
| Manufacturer Address | 101 W. WALNUT STREET GARDENA CA 902481429 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-09-30 |