MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2006-12-09 for SUPERARM 2000E NA manufactured by Handicaps, Inc..
[541011]
Full narrative report available by request; contact jeanenne, 303-781-2062. Patient's assistant was loading patient on lift system. Assistant reached over the lift and placed herself between lift and roof of the van. Some clothing or other item caught on the operation switch and pinned herself between the lift and the roof of the van "squishing" her. Safety system did operate since she was not crushed. She was able to hit the emergency override, but since what ever was depressing the toggle was not removed, the lift just chattered, and "acted crazy". She was aided by others who freed her and "tore the lift apart". She was taken by ambulance to the hospital where she was seen and released. Diagnosis according to the assistant was back spasms and she was referred to a chiropractor for further follow up. User's father is purchasing a new unit for the user. After speaking with him, he says that he is not sure if he wants to make the lift available for factory return, and will have to think on that. Follow up is being pursued by handicaps, inc, the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
[8054983]
Event is still in the process of investigation. Corrective and preventative team is meeting to determine correct action. We are continuing in communication with the client's family to reach resolution. The manufacturer believes that this adverse event took place because of improper use, inadequate training to the assistant. The lift motor possesses sufficient strength to knock out a closed door, or crush bones and potentially cause death if used improperly. It is for that reason that the electric eye safeties are put in place. It is handicaps' opinion that the safety system preformed it's function, although it caused discomfort the lift arm stopped before it caused serious injury or death. Preventative and corrective team is working on relabeling and additional training programs for dealers and end users.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1720406-2006-00001 |
| MDR Report Key | 797455 |
| Report Source | 04,05 |
| Date Received | 2006-12-09 |
| Date of Report | 2006-12-08 |
| Date of Event | 2006-11-27 |
| Date Mfgr Received | 2006-12-04 |
| Device Manufacturer Date | 2002-07-01 |
| Date Added to Maude | 2006-12-26 |
| 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 | JEANENNE PHILLIPS |
| Manufacturer Street | 4335 S. SANTA FE. DR. |
| Manufacturer City | ENGLEWOOD CO 80110 |
| Manufacturer Country | US |
| Manufacturer Postal | 80110 |
| Manufacturer Phone | 3037812062 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPERARM |
| Generic Name | VAN LIFT FOR THE DISABLED |
| Product Code | ING |
| Date Received | 2006-12-09 |
| Model Number | 2000E |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 784988 |
| Manufacturer | HANDICAPS, INC. |
| Manufacturer Address | * ENGLEWOOD CO * US |
| Baseline Brand Name | SUPERARM |
| Baseline Generic Name | VAN LIFT FOR THE DISABLES |
| Baseline Model No | 2000E |
| Baseline Catalog No | NA |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-12-09 |