MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-10-09 for DIAGNOST 76 PLUS 9848-500-16202 NA manufactured by Philips Systems Medezin.
[17423443]
Reportedly, the pt was positioned prone on table with his head at the foot end of table for ercp exam. The pt's hands were positioned above his head and flat on table top with palms down. Allegedly, the table top moved longitudinally out of position by itself toward the head end of the table resulting in the need to reposition the table top by the technologist. During repositioning, the technologist did not notice that the pt had moved his hands toward the foot end of the table and reportedly the pt's fingers caught between the bottom of the table top and the barium shield cover resulting in a laceration and fracture of the 4th finger on his left hand. The pt was taken to surgery for displaced fracturer of left 4th finger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217116-1998-00025 |
| MDR Report Key | 191467 |
| Report Source | 05,06 |
| Date Received | 1998-10-09 |
| Date of Report | 1998-09-10 |
| Date of Event | 1998-09-10 |
| Date Facility Aware | 1998-09-10 |
| Report Date | 1998-09-10 |
| Date Reported to FDA | 1998-09-10 |
| Date Reported to Mfgr | 1998-09-10 |
| Date Mfgr Received | 1998-09-10 |
| Date Added to Maude | 1998-10-15 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAGNOST 76 PLUS |
| Generic Name | GENERAL PURPOSE R/F SYSTEM |
| Product Code | IXL |
| Date Received | 1998-10-09 |
| Model Number | 9848-500-16202 |
| Catalog Number | NA |
| 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 | 182335 |
| Manufacturer | PHILIPS SYSTEMS MEDEZIN |
| Manufacturer Address | ROENTGENSTRASSE 24 HAMBURG HAMBURG GM 2000 |
| Baseline Brand Name | DIAGNOST 76 PLUS |
| Baseline Generic Name | GENERAL PURPOSE R/F SYSTEM (SPOT FILM/IMAGE INTENSIFIED) |
| Baseline Model No | 9848-500-16202 |
| 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 | 1. Required No Informationntervention | 1998-10-09 |