MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-05-04 for SUPERARM LIFT 2000E manufactured by Handicaps, Inc..
[1498386]
I, (b) (4) received a phone call from a man in (b) (6). He said his sister had a van with a superarm in it, and she was killed in an accident on (b) (6) 2010. The man also said they had just recently gotten her a new electric wheelchair that was about (b) (6). I (b) (4) told him how sorry we were for his loss. He then stated that he wanted to sell the vehicle. He further stated that the vehicle and the lift were not damaged in the accident. He wanted to know how and where to sell the vehicle with the equipment in it, and i suggested he could call one of our dealers in (b) (6), also suggested putting an ad on the bulletin board at a rehab hospital and to give me his information, and i would put it on our bulletin board. He said he was also going to put an ad on (b) (6) and (b) (6). He told me it was a (b) (4) with the superarm lift and hand controls and when i asked the mileage, he said he didn't know but it was over 100,000 miles. I asked how much he wanted for it and he didn't know. I suggested consulting a bluebook for the vehicle price. I then asked, what was his sister's name. He told me. I again told him how sorry i was to hear about her passing and that i had met her when she came to (b) (6) and had spoken to her several times on the phone over the years. Then he told me that he and his family think she just got her wheelchair in the wrong place, and the bar crushed her chest. Up to this point, i was not aware what type of accident she had and i asked, "was that the superarm lift bar? " he said yes, you know she was a large woman and there was no sign of struggle, she still had the keys in her left hand and didn't even raise her arms like she was trying to grab the bar or anything. She didn't even drop the keys like you would think. He believes she felt no pain since it was so quick. Her brother went on to said he and his family still cant figure out what happened. He thinks maybe she had a cardiac arrest. He said there was no autopsy performed since the coroner said her chest was crushed by the bar. So they just didn't think about having an autopsy performed to see if she had a heart attack. Her brother went on to say that he and his family checked the lift over, and the safety electric eyes still worked every time the way they were supposed to, and the toggle switches were not sticking, he tried to make them stick but the minute he moved them and let up, they were just fine. "it is just a mystery to us how it could have happened" her brother said. As i, (b) (4) was trying to find out exactly what happened, he told me that the webbing strap on the right side was not hooked up to the arm, and maybe she realized it wasn't hooked and ran the arm back in to hook it up and didn't let up on the switch. He also said the front wheels were off the ground. (i think he meant off the van floor). The customer's brother said she was in the process of getting out, but was still sitting in the van. I explained that with an electric chair you also have to power the chair back when it lands on the floor because the wheels won't turn if you don't. I offered possible scenarios that maybe she drove the chair forward instead of back, or didn't power back her chair, or accidently turned off the chair instead of powering it back. And her brother said, he didn't know, and that it was a mystery to everyone. We ended our phone conversation with me saying that i would try to help him how i could to sell their van by putting it on our bulletin board to tell people looking for a vehicle in his area and told him that i understood what grief there was when a death happens. Her brother thanks me for my concern and understanding.
Patient Sequence No: 1, Text Type: D, B5
[8470876]
The vehicle and lift are in (b) (6). Her brother said, he and his family checked all the switches, both electric eye safety devices and toggle switches and checked it for malfunction and everything on it still works just fine. Her own family feels it had to have been operator error on her part or possibly a heart attack. Her brother said they did not do an autopsy because the coroner said, her chest was crushed by the bar.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1720406-2010-00001 |
| MDR Report Key | 1678431 |
| Report Source | 00 |
| Date Received | 2010-05-04 |
| Date of Report | 2010-04-26 |
| Date of Event | 2010-04-01 |
| Date Mfgr Received | 2010-04-26 |
| Date Added to Maude | 2010-05-12 |
| 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 | GERALDINE O'DELL |
| Manufacturer Street | 4335 S. SANTA FE DR. |
| Manufacturer City | SHERIDAN CO 80110 |
| Manufacturer Country | US |
| Manufacturer Postal | 80110 |
| Manufacturer Phone | 3037812062 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPERARM LIFT |
| Generic Name | WHEELCHAIR LIFT |
| Product Code | ING |
| Date Received | 2010-05-04 |
| Model Number | 2000E |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANDICAPS, INC. |
| Manufacturer Address | SHERIDAN CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2010-05-04 |