MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-12 for MEDCARE STAND AND WEIGH 400007 manufactured by Medcare.
[24112612]
The lift was inspected by the facility maintenance supervisor and found to be operating correctly. The last preventative maintenance performed on the device was in march 2015 and this is a first time occurrence for this type of incident. The lift is not being returned for evaluation. We reenacted how this could occur in several ways with similar results as what occurred in the facility following improper foot placement by not having both feet entirely on the loft. Therefore, we believe the patient was not standing with booth heels on the platform fully and caused the lift to tilt to one side.
Patient Sequence No: 1, Text Type: N, H10
[24112613]
Lift tilted while in use with a patient. Facility reported the individual stepped on the edge of the platform causing it to tilt to one side. The facility indicated no injuries occurred to report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007802293-2015-00032 |
| MDR Report Key | 5011600 |
| Date Received | 2015-08-12 |
| Date of Report | 2015-08-11 |
| Date of Event | 2015-07-02 |
| Date Mfgr Received | 2015-07-16 |
| Device Manufacturer Date | 2011-03-01 |
| Date Added to Maude | 2015-08-18 |
| 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 | STEVE KILBURN |
| Manufacturer Street | 10888 METRO CT |
| Manufacturer City | MARYLAND HEIGHTS MO 63043 |
| Manufacturer Country | US |
| Manufacturer Postal | 63043 |
| Manufacturer Phone | 3142198614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDCARE STAND AND WEIGH |
| Generic Name | MEDCARE STAND AND WEIGH |
| Product Code | FNG |
| Date Received | 2015-08-12 |
| Model Number | 400007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDCARE |
| Manufacturer Address | BURNSVILLE MN 55337 US 55337 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-12 |