MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-12-22 for SYNERGY SYSTEM CONFIGURED WITH CART SYNERGY CART manufactured by Cardinal Health 209.
[999960]
Customer reported that the tech is suffering from carpal tunnel syndrome (cts). Report from centra medical center: "a centra health system eeg tech has a workman's comp case for having worked at eeg system for long hours. The eeg machine workstation is not ergonomically correct. When the tech sits at the machine there is no place for the tech's legs to go. It is very awkward to work at this machine. It is reported that the tech will undergo surgery for cts. Centra workman's comp manager advised that the eeg tech is suffering from cts due to the keyboard being too high for her when she sits at the machine. He believes that the cause of her injuries is the inappropriate height of the keyboard for her size and stature. The effect is that her posture is not ergonomically correct while working at the machine, resulting in stress on her hands and wrists and pressure on the median nerve. Squeezing and irritation of the median nerve can lead to cts.
Patient Sequence No: 1, Text Type: D, B5
[8170671]
Same technician also used one of our eeg systems (nicoletone veeg). This system is also implicated in this same case.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2126317-2008-00005 |
| MDR Report Key | 1273116 |
| Report Source | 06 |
| Date Received | 2008-12-22 |
| Date of Report | 2008-12-02 |
| Date of Event | 2008-01-01 |
| Date Mfgr Received | 2008-11-21 |
| Device Manufacturer Date | 2008-02-01 |
| Date Added to Maude | 2009-01-08 |
| 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 | GLEN HERMANSON |
| Manufacturer Street | 5225-2 VERONA RD. |
| Manufacturer City | MADISON WI 53711 |
| Manufacturer Country | US |
| Manufacturer Postal | 53711 |
| Manufacturer Phone | 6082735000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNERGY SYSTEM CONFIGURED WITH CART |
| Generic Name | ELECTROMYOGRAPH, DIAGNOSTIC |
| Product Code | GWE |
| Date Received | 2008-12-22 |
| Model Number | SYNERGY CART |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 209 |
| Manufacturer Address | MADISON WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-12-22 |