MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-08-03 for CASCADE TRANSFER LIFT 383000-1L manufactured by Penner Manufacturing, Inc..
[23965959]
Device was inspected on 04/24/2015 and found to be in good condition. Interviews were conducted along with in house training on lift transfer. Employees were trained to use the brakes and all supplied belts during use with residents. Prior to inspection additional safety belts were ordered and rec'd by facility. Both the maintenance supervisor and the director of nursing both said that they believed that the belts were not being used at the time of the incident. It was also discussed that because of the size of the resident that more than one cna should be helping because one isn't enough to help just due to the size of a (b)(6) pound resident and the cna who is just over 5' and just over 100 pounds.
Patient Sequence No: 1, Text Type: N, H10
[23965960]
Resident had just been given a bath and was taken out of the tub by the cna and resident went to reach for a towel to help cna dry him off and resident fell forward out of transfer and hit head on floor of bathing room. Resident was taken to the emergency room and evaluated. It was discovered that the resident had a concussion and a black eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1922538-2015-00001 |
| MDR Report Key | 4990447 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-08-03 |
| Date of Report | 2015-08-03 |
| Date of Event | 2015-04-17 |
| Date Facility Aware | 2015-04-20 |
| Report Date | 2015-08-03 |
| Date Mfgr Received | 2015-04-20 |
| Device Manufacturer Date | 2013-06-01 |
| Date Added to Maude | 2015-08-11 |
| 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 | PATRICK WALL |
| Manufacturer Street | 101 GRANT ST |
| Manufacturer City | AURORA NE 68818 |
| Manufacturer Country | US |
| Manufacturer Postal | 68818 |
| Manufacturer Phone | 4026945003 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CASCADE TRANSFER LIFT |
| Generic Name | CASCADE TRANSFER LIFT |
| Product Code | FNG |
| Date Received | 2015-08-03 |
| Model Number | 383000-1L |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PENNER MANUFACTURING, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-03 |