MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-09-20 for MULTIX TOP 00451450 manufactured by Siemens Ag, Medical Solutions.
[2260075]
Siemens healthcare became aware of the reported event through a medwatch report (b)(4) filed by the customer. A f/u call was made to the customer. According to the biomedical engineering supervisor, gary guyton, an elderly pt was being prepped for a shoulder x-ray on the multix sys. The pt was leaning on the table when the table floated causing her to fall. The pt fell on the floor and broke her hip. She was hospitalized at the facility.
Patient Sequence No: 1, Text Type: D, B5
[9353731]
According to the biomedical engineering supervisor, (b)(4), the unit power was removed from the sys possibly due to a power loss. The sys is equipped with a floating table top that may move when the unit looses power. The described event occurred due to the pt leaning on the table when the unit lost power. The reported issue appears to be a first occurrence and no similar issues have been reported from the field.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2240869-2011-00039 |
| MDR Report Key | 2274711 |
| Report Source | 06 |
| Date Received | 2011-09-20 |
| Date of Report | 2011-09-19 |
| Date of Event | 2011-07-16 |
| Date Mfgr Received | 2011-08-26 |
| Date Added to Maude | 2011-10-05 |
| 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 | ANASTASIA MASON |
| Manufacturer Street | 51 VALLEY STREAM PKWY. MS G01 |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6102194834 |
| Manufacturer G1 | SIEMENS AG, MEDICAL SOLUTIONS |
| Manufacturer Street | ROENTGENSTRASSE 19-21 |
| Manufacturer City | KEMNATH 95478 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 95478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTIX TOP |
| Generic Name | TABLE, RADIOGRAPHIC, NON-TILTING, POWER |
| Product Code | IZZ |
| Date Received | 2011-09-20 |
| Model Number | 00451450 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS AG, MEDICAL SOLUTIONS |
| Manufacturer Address | ROENTGENSTRASSE 19-21 KEMNATH 95478 GM 95478 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-09-20 |