MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-03-25 for DIAGNOST 76 PLUS 9848-500-16202 NA manufactured by Philips Systeme Medezin.
[17909192]
During an upper gi film, as the table was being lowered from a vertical to a horizontal position, the spot film device carriage allegedly started to slowly slip downward until it was resting on the pt's chest. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217116-1997-00012 |
| MDR Report Key | 80471 |
| Report Source | 06 |
| Date Received | 1997-03-25 |
| Date of Report | 1997-03-06 |
| Date of Event | 1997-03-05 |
| Date Facility Aware | 1997-03-05 |
| Report Date | 1997-03-06 |
| Date Reported to FDA | 1997-03-25 |
| Date Reported to Mfgr | 1997-03-07 |
| Date Mfgr Received | 1997-03-07 |
| Date Added to Maude | 1997-04-03 |
| 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 |
| Reporter Occupation | RADIOLOGIC TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAGNOST 76 PLUS |
| Generic Name | RADIOGRAPHY/FLUOROSCOPY TABLE |
| Product Code | IXL |
| Date Received | 1997-03-25 |
| Model Number | 9848-500-16202 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 79939 |
| Manufacturer | PHILIPS SYSTEME MEDEZIN |
| Manufacturer Address | * HAMBURG GM |
| 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. Other | 1997-03-25 |