MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-07-05 for SUMMIT STAIRWAY LIFT AC UNIT manufactured by Summit Lifts, Inc..
[3320785]
"he stated lift was installed (b)(6) 2004, and had been used infrequently until recently. He disassembled lift to determine why the slack cable safety device was preventing lift from operating freely. He said safety device was setting whether or not weight was on the unit. He took the lift out of the track after removing the top 2' section of track. He cleaned the track, and modified the safety device by turning the cone point allen screw half turn inward. He then attempted to put the lift back together to see if it would work better. (my notes: lifts are sent out on 2' sections of track from the factory. I told him, the safety devices are calibrated, loctite, and are not intended to be adjusted in the field under any circumstances). In testing the lift, he sat on it to ride it down. The lift went down the track at a rate sufficient enough to damage the end of the track, ejecting him from the chair and resulting in him breaking a bone in his shoulder. I asked him how he thought that happened because the safety device is designed to prevent this type of incident. He said he did something "stupid" when putting the lift back together. In some manner, he had assembled the lift back to the track, but didn't get the uphill set of wheels in the track, but didn't get the uphill set of wheels in the track channel properly, allowing them to ride above the track, thereby eliminating the safety device from engaging.
Patient Sequence No: 1, Text Type: D, B5
[10605821]
User stated header assembly went down with the lift. (my notes: in house testing indicates the header would remain in place if assembled to the track correctly - even if the screws were left out. Therefore, it would appear the header was not put on the end of the track correctly or not at all). He asked what we could do to get the lift working properly, stating his son had come over and reassembled the lift to the track. I told him he could ship the lift back to our facility and we would be glad to go through the unit 100% to make sure all components were in working order. He declined this offer. He said he used a piece of metal to disable the safety device so his wife could use the lift. I strongly advised him against this type of modification, stating that i could never recommend the use of any of our lifts with any safety devices disabled. He said he understood, but then went on to attempt to get me to ok use of the lift, asking about the likelihood of a gear failing, design of the gear box, etc. I reiterated, he nor anyone else should not use the lift with the safety device disabled. I provided him the name of a local dealer to come out to look at the lift to determine if the lift could be put back into proper working order. He said he didn't want to pay too much for this service. I stated the dealer in his area had a good working understanding of lifts and strongly advised he have him come to his home and call me so i could obtain additional information to make a judgement about the condition of the equipment. " we have no record of (b)(6) or anyone else calling us about any problems with this lift until this event was reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004153586-2006-00001 |
| MDR Report Key | 3031165 |
| Report Source | 04 |
| Date Received | 2006-07-05 |
| Date of Report | 2006-07-05 |
| Date of Event | 2006-06-28 |
| Report Date | 2006-07-05 |
| Date Reported to FDA | 2006-07-05 |
| Date Reported to Mfgr | 2006-07-05 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2013-04-08 |
| 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 | 3 |
| Manufacturer Street | 18505 E. 163RD STREET |
| Manufacturer City | LAKE WINNEBAGO MO 64034 |
| Manufacturer Country | US |
| Manufacturer Postal | 64034 |
| Manufacturer Phone | 8165370661 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUMMIT STAIRWAY LIFT |
| Generic Name | PATIENT POWERED TRANSPORT DEVICE-STAIR LIFT |
| Product Code | ILK |
| Date Received | 2006-07-05 |
| Model Number | AC UNIT |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUMMIT LIFTS, INC. |
| Manufacturer Address | LAKE WINNEBAGO MO 64034 US 64034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-07-05 |