MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2006-12-22 for DEVICE #1 ADVANCED CONTROL BASE, JACKSON MODULAR TABLE SYST 5803 manufactured by Orthopedic Systems, Inc..
[18513340]
The pt was undergoing hip arthroplasty, and after the distraction of the right hip joint was applied, an attempt was made to tilt the table for better access. The anesthesiologits was unfamiliar with the bed and did not know it would not rotate 180 degrees. She was unable to get the bed to tilt using the hand control and seeing the "lock/unlock" lever on the bed, she unlocked it thinking that was why the bed would not tilt. The tabletop rotated and the pt was left dangling by the two safety straps (across chest and unaffected leg). The healthcare team reacted swiftyly and was able to maintain the security of his airway and reorient the bed. He was moved to another bed.
Patient Sequence No: 1, Text Type: D, B5
[18718504]
Device was repaired. User allowed maintenance of table to go beyond safe use. Repair order created, items for repair identified replacement actuator and knob replacement assembly. Table is currently in use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921578-2006-00005 |
| MDR Report Key | 800552 |
| Report Source | 00 |
| Date Received | 2006-12-22 |
| Date of Report | 2006-12-22 |
| Date of Event | 2006-10-20 |
| Date Mfgr Received | 2006-12-07 |
| Device Manufacturer Date | 2004-06-01 |
| Date Added to Maude | 2007-01-08 |
| 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 |
| 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 | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEVICE #1 ADVANCED CONTROL BASE, JACKSON MODULAR TABLE SYST |
| Generic Name | OPERATING ROOM TABLE |
| Product Code | BWN |
| Date Received | 2006-12-22 |
| Model Number | 5803 |
| Catalog Number | 5803 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 788090 |
| Manufacturer | ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Address | 30031 AHERN AVE UNION CITY CA 945871234 US |
| Baseline Brand Name | DEVICE #1 ADVANCED CONTROL BASE, JACKSON MODULAR TABLE SYST |
| Baseline Generic Name | OPERATING ROOM TABLE |
| Baseline Model No | 5803 |
| Baseline Catalog No | 5803 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-12-22 |