MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-01-02 for PHILIPS SL NA manufactured by Philips Medical Systems Radiotherapy.
[18478873]
The cassette holder fell, grazing the pt without causing any injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217116-1996-00037 |
| MDR Report Key | 61550 |
| Report Source | 06 |
| Date Received | 1997-01-02 |
| Date of Report | 1996-12-11 |
| Date of Event | 1996-12-04 |
| Date Facility Aware | 1996-12-04 |
| Report Date | 1996-12-11 |
| Date Reported to Mfgr | 1996-12-04 |
| Date Mfgr Received | 1996-12-04 |
| Date Added to Maude | 1997-01-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS |
| Generic Name | SIMULATOR |
| Product Code | IXY |
| Date Received | 1997-01-02 |
| Model Number | SL |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 61900 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS RADIOTHERAPY |
| Manufacturer Address | * CRAWLEY UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-01-02 |