MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-07-10 for DIAGNOST 76 9870-694-12172 MRF5102 manufactured by Philips Ystems Medezin.
[104598]
Reportedly, while infant child was being x-rayed, the collimator lamp cover on the r/f system alleged detached from the collimator and struck the infant child in the forehead resulting in a bump on the child's forehead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217116-1998-00018 |
| MDR Report Key | 176761 |
| Report Source | 05 |
| Date Received | 1998-07-10 |
| Date of Report | 1998-06-11 |
| Date of Event | 1998-06-11 |
| Date Facility Aware | 1998-06-11 |
| Report Date | 1998-06-11 |
| Date Reported to Mfgr | 1998-06-11 |
| Date Mfgr Received | 1998-06-11 |
| Date Added to Maude | 1998-07-15 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAGNOST 76 |
| Generic Name | R/F SYSTEM (SPOT FILM/IMAGE INTENSIFIED) |
| Product Code | IXL |
| Date Received | 1998-07-10 |
| Model Number | 9870-694-12172 |
| Catalog Number | MRF5102 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 171847 |
| Manufacturer | PHILIPS YSTEMS MEDEZIN |
| Manufacturer Address | ROENTGENSTRASSE 24 HAMBURG GM 2000 |
| Baseline Brand Name | DIAGNOST 76 |
| Baseline Generic Name | GENERAL PURPOSE R/F SYSTEM (SPOT FILM/IMAGE INTENSIFIED) |
| Baseline Model No | 9870-694-12172 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | DIAGNOST 76 FAMILY |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K924593 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-07-10 |