MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-03-12 for DIAGNOST 76 PLUS 9848-500-16202 NA manufactured by Philips Systeme Medezin.
[92507]
Reportedly, during a colon exam, when the tabletop was moved towards the head end, the pt's hand/fingers were pinched between the underside of the tabletop and the table frame. Reportedly, the pt was x-rayed for fractures and then was taken to er for possible sutures. The pt returned two days later with infection in tendon of pinched finger requiring iv therapy. Pt was admitted to hosp and required subsequent surgery on injured finger to remove infection. Reportedly, the tabletop was found to be installed in reverse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217116-1998-00006 |
| MDR Report Key | 156154 |
| Report Source | 05,06 |
| Date Received | 1998-03-12 |
| Date of Report | 1998-02-09 |
| Date of Event | 1998-02-05 |
| Date Facility Aware | 1998-02-05 |
| Report Date | 1998-02-09 |
| Date Reported to FDA | 1998-02-12 |
| Date Reported to Mfgr | 1998-02-09 |
| Date Mfgr Received | 1998-02-09 |
| Date Added to Maude | 1998-03-18 |
| 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 | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAGNOST 76 PLUS |
| Generic Name | GENERAL PURPOSE R/F SYSTEM |
| Product Code | IXL |
| Date Received | 1998-03-12 |
| 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 | 152113 |
| 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. Hospitalization; 2. Other; 3. Required No Informationntervention | 1998-03-12 |