MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-20 for PINNACLE HEAVY DUTY SL600HD manufactured by Harmar Mobility, Llc.
[114806252]
This type of product performance issue has not been reported previously. During the on-site incident investigation, several screws that connect the chassis motor to the frame were found to be loose or missing. The unit was sent to harmar for further investigation in may where it was determined that the screws were loose or missing due to the lack of loctite threadlocker application on the screws.
Patient Sequence No: 1, Text Type: N, H10
[114806253]
On (b)(6) 2018 the user got on the stair lift chair at the bottom step and was riding upwards to the top landing when the stair lift made a popping sound and the stair lift seat/chassis descended back down the staircase to the end of the rail. The user stepped off the stair lift as it descended and sustained minor pain in her leg and a small cut on her finger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004153586-2018-00001 |
| MDR Report Key | 7705796 |
| Date Received | 2018-07-20 |
| Date of Report | 2018-07-17 |
| Date of Event | 2018-05-05 |
| Date Mfgr Received | 2018-05-08 |
| Device Manufacturer Date | 2018-04-23 |
| Date Added to Maude | 2018-07-20 |
| 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 Contact | MS. DAWN WATTERS |
| Manufacturer Street | 2075 47TH STREET |
| Manufacturer City | SARASOTA FL 34234 |
| Manufacturer Country | US |
| Manufacturer Postal | 34234 |
| Manufacturer Phone | 9413087398 |
| Manufacturer G1 | HARMAR MOBILITY |
| Manufacturer Street | 18505 E 163RD STREET |
| Manufacturer City | LAKE WINNEBAGO MO 64034 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 64034 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PINNACLE HEAVY DUTY |
| Generic Name | POWERED STAIRWAY CHAIR LIFT |
| Product Code | PCD |
| Date Received | 2018-07-20 |
| Returned To Mfg | 2018-05-10 |
| Model Number | SL600HD |
| Catalog Number | SL600HD |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HARMAR MOBILITY, LLC |
| Manufacturer Address | 18505 E 163RD STREET LAKE WINNEBAGO MO 64034 US 64034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-20 |