MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1997-04-10 for ZENITH 240 NA manufactured by Williams Healthcare Systems.
[48446]
Dr was operating table without left hand upper and lower shroud stops. Pt moved hand from armrest and lifted shroud with his left hand. When the dr operated the table the pt's finger was pinched in the table mechanism. Sutures were required to repair damage to finger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415746-1997-00001 |
| MDR Report Key | 83726 |
| Report Source | 08 |
| Date Received | 1997-04-10 |
| Date of Report | 1997-03-10 |
| Date of Event | 1997-03-07 |
| Date Mfgr Received | 1997-03-10 |
| Device Manufacturer Date | 1988-09-01 |
| Date Added to Maude | 1997-04-16 |
| 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 | ZENITH |
| Generic Name | CHIROPRACTIC TABLE |
| Product Code | INQ |
| Date Received | 1997-04-10 |
| Model Number | 240 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 83031 |
| Manufacturer | WILLIAMS HEALTHCARE SYSTEMS |
| Manufacturer Address | 158 NORTH EDISON AVE. ELGIN IL 60123 US |
| Baseline Brand Name | ZENITH |
| Baseline Generic Name | CHIROPRACTIC TABLE |
| Baseline Model No | 240 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | VERTI-LIFT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-04-10 |