MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-04-16 for JACKSON TABLE 5892 NA manufactured by Orthopedic Systems Inc..
[305777]
The pt was being prepared to undergo multiple spinal procedures. Once the pt was placed in the prone position on the jackson table, and the table was locked into place, and during the time that the pt was being positioned, the bed's locking swivel broke loose, nearly causing the pt to fall off of the frame. Several members of the nursing staff immediately caught the pt, who was not harmed in any way. A new jackson table was brought into the operative field, and it performed appropriately well. The pt was not adversely impacted by this event, nor was the surgery extended for any appreciable amount of time.
Patient Sequence No: 1, Text Type: D, B5
[326672]
Add'l info received from mfr 6/30/03: in the mdr filed on this incident, the user facility indicated that "the bed's locking swivel broke loose, nearly causing the pt to fall off the frame". It also indicates that "the table was locked into place". If this was the case, the failure of this component would not constitute a safety issue of the pt. The osi user guide clearly explains the procedure where both the 180 degree rotation lock (commonly known as the head end brake) and the rotation safety lock (commonly known as the foot end brake) be engaged prior to pt transfer. These locks provide a redundant locking condition so that if these two locks are engaged, there is no possibility that the table can move unexpectedly as this report suggests. This is true even in the case if the screw mentioned above fails. In other words, these two redundant brakes will hold the table secure under any failure condition. The only conclusion that can be drawn from this report is that the user did not properly engage the rotation safety lock prior to pt transfer. The locked condition of these brakes is indicated by two indicator lights at the head end of the table. The procedure states that a pt should not be transferred to the table unless both of these lights are illuminated. Co must conclude that the user operated the device improperly and the only reason that the table moved is because it was not locked. In regard to the failed screw, it has been repaired and the table is confirmed to be functioning correctly. In addition, an osi rep has visited this facility to re-educate them on proper use of the table. There were no failures reported of the power source of the table and this is not a life-sustaining device, so there is no info to report in this regard.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1028158 |
| MDR Report Key | 454458 |
| Date Received | 2003-04-16 |
| Date of Report | 2003-04-07 |
| Date of Event | 2003-03-27 |
| Date Added to Maude | 2003-04-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JACKSON TABLE |
| Generic Name | SURGICAL SPINAL TABLE |
| Product Code | FWY |
| Date Received | 2003-04-16 |
| Model Number | 5892 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 443460 |
| Manufacturer | ORTHOPEDIC SYSTEMS INC. |
| Manufacturer Address | 30031 AHERN AVE UNION CITY CA 94587 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-04-16 |