MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-12-18 for CHEST STAND C-9800R manufactured by Trex Medical Inc.
[773761]
Hologic received a report in 2007 from philips, who functions as a service provider for the hosp that owns the unit. The report stated that during positioning of a pt for a chest exam, the radiation technologist adjusted the pt support device, and the device released by itself and struck the pt on the head. The service engineer from philips found broken tension spring in the support device. Since this prod is no longer supported, and parts are not available to repair the equipment, the service engineer removed the pt support device from service.
Patient Sequence No: 1, Text Type: D, B5
[7929893]
Hologic contacted the radiological tech. The radiological tech told us that the injury to the pt related to this incident was very minor, and no medical intervention was required. The device could not be repaired, as parts are no longer available. The pt support device was removed from service. Trex medical is no longer in business, and the device is no longer manufactured.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221300-2007-00007 |
| MDR Report Key | 971522 |
| Report Source | 00 |
| Date Received | 2007-12-18 |
| Date of Report | 2007-12-11 |
| Date of Event | 2007-10-29 |
| Date Mfgr Received | 2007-11-14 |
| Device Manufacturer Date | 1999-10-01 |
| Date Added to Maude | 2008-04-10 |
| 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 | ARTHUR FRIEDMAN, VP |
| Manufacturer Street | 35 CROSBY DR. |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal | 01730 |
| Manufacturer Phone | 7819997368 |
| Manufacturer G1 | TREX MEDICAL |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHEST STAND |
| Generic Name | X-RAY DEVICE |
| Product Code | IYB |
| Date Received | 2007-12-18 |
| Model Number | C-9800R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 974373 |
| Manufacturer | TREX MEDICAL INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-18 |