MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-11-10 for MIDLAND HI-LO ELECTRIC TABLE 6013ED manufactured by Patterson Medical Holdings.
[16922344]
The hand control for the hi-lo electric table dropped into the frame of the table as the table was in motion, causing the table stay in motion. As the therapist reached to free the hand control from the moving table, her middle finger was caught between the frame of the table and the hand control creating a pinch point which severed her middle finger off her right hand. She had surgery to reattach the aforementioned digit.
Patient Sequence No: 1, Text Type: D, B5
[17041718]
The incident was caused by the hand control falling into the unit and the clinician not removing power to the device prior to removal of the hand control. The clearances in the area around the lift arms where the finger are either under 0. 125 inches or over 1. 0 inches to prevent a scissors type condition. The unit was operating as designed and the failure occurred due to user error. The issue does not require any modifications to prevent re-occurrence of this issue in the future.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1048003-2011-00005 |
| MDR Report Key | 2384846 |
| Report Source | 06 |
| Date Received | 2011-11-10 |
| Date of Report | 2011-10-25 |
| Date of Event | 2011-10-24 |
| Date Facility Aware | 2011-10-25 |
| Report Date | 2011-11-03 |
| Date Reported to FDA | 2011-11-09 |
| Date Reported to Mfgr | 2011-11-09 |
| Date Mfgr Received | 2011-10-25 |
| Device Manufacturer Date | 1993-09-01 |
| Date Added to Maude | 2011-12-23 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | W68 N158 EVERGREEN DR. |
| Manufacturer City | CEDARBURG WI 53012 |
| Manufacturer Country | US |
| Manufacturer Postal | 53012 |
| Manufacturer Phone | 2623878724 |
| Manufacturer G1 | MIDLAND MFG. |
| Manufacturer Street | 802 UNIVERSAL DR. |
| Manufacturer City | COLUMBIA SC 29209512 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29209 5120 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIDLAND HI-LO ELECTRIC TABLE |
| Product Code | INQ |
| Date Received | 2011-11-10 |
| Model Number | 6013ED |
| Catalog Number | 6013ED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 18 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PATTERSON MEDICAL HOLDINGS |
| Manufacturer Address | BOLINGBROOK IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-11-10 |