MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-08-31 for DIAGNOST 76 9870-694-12172 NA manufactured by Philips Medical Systems.
[710857]
This report is being filed upon notification from our mfr in another country of an event that occurred in that country in another city. During a break between patient exams with the system in standby and in its upright position (+90 degrees) the tow steel bands supporting the serial changer / counterweight broke. The carriage fell down, overran the mechanical end stop and finally stopped on the floor. No injury occurred since there were no persons present in the room.
Patient Sequence No: 1, Text Type: D, B5
[8125882]
The investigation is still ongoing on this event. When the investigation is completed, a follow-up report will be sent to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217116-2007-00023 |
| MDR Report Key | 907119 |
| Report Source | 05 |
| Date Received | 2007-08-31 |
| Date of Report | 2007-08-06 |
| Date of Event | 2007-08-01 |
| Date Mfgr Received | 2007-08-06 |
| Date Added to Maude | 2009-10-19 |
| 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 | DREW QUEEN |
| Manufacturer Street | 22100 BOTHELL EVERETT HWY. |
| Manufacturer City | BOTHELL WA 98041 |
| Manufacturer Country | US |
| Manufacturer Postal | 98041 |
| Manufacturer Phone | 4254877199 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Street | ROENTGENSTRASSE 24 |
| Manufacturer City | HAMBURG 2000 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 2000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAGNOST 76 |
| Generic Name | IXL - GENERAL PURPOSE R/F SYSTEM |
| Product Code | IXL |
| Date Received | 2007-08-31 |
| Model Number | 9870-694-12172 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | ROENTGENSTRASSE 24 HAMBURG 2000 GM 2000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-31 |