MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-09-01 for JST-2000 CHEST SUPPORT PLATE 5840-580 manufactured by Orthopedic Systems, Inc..
[429772]
Jackson table was used to position a pt in the prone position. The pt was log rolled from the bed to the jackson table. The chest support broke on both ends and the pt was without upper chest support for 10 seconds. The pt was placed back on the bed, awakened from general anesthesia and checked. No injury was noted at that time. Surgery was cancelled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2921578-2005-00003 |
| MDR Report Key | 633776 |
| Report Source | 06 |
| Date Received | 2005-09-01 |
| Date of Report | 2005-08-18 |
| Date of Event | 2005-07-19 |
| Date Mfgr Received | 2005-07-19 |
| Date Added to Maude | 2005-09-12 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | KIRKE JAYNE |
| Manufacturer Street | 30031 AHERN AVE |
| Manufacturer City | UNION CITY CA 945871234 |
| Manufacturer Country | US |
| Manufacturer Postal | 945871234 |
| Manufacturer Phone | 5104768128 |
| Manufacturer G1 | * |
| Manufacturer Street | 30031 AHERN AVE |
| Manufacturer City | UNION CITY CA 94587123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94587 1234 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JST-2000 CHEST SUPPORT PLATE |
| Generic Name | PATIENT SUPPORT |
| Product Code | FWY |
| Date Received | 2005-09-01 |
| Returned To Mfg | 2005-08-15 |
| Model Number | 5840-580 |
| Catalog Number | 5840-580 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 623348 |
| Manufacturer | ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Address | 30031 AHERN AVE. UNION CITY CA 945871234 US |
| Baseline Brand Name | JST-2000 CHEST SUPPORT PLATE |
| Baseline Generic Name | SUPPORT PLATE |
| Baseline Model No | 5840-580 |
| Baseline Catalog No | 5855-838 |
| Baseline Device Family | ORTHOOPEDIC TABLE SYSTEM |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-09-01 |