MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-19 for CEILING LIFT 625 (LIFTS UP TO 625 LBS.) 323120 manufactured by Medcare Products.
[77831605]
Patient Sequence No: 1, Text Type: N, H10
[77831606]
The nurse used the hand remote to lower the sling of the ceiling lift and then to raise the patient from the bed. When she tried to lower the patient to the wheelchair the lift did not move. At that point she pulled the emergency cord to lower the patient and it failed to do so. Later investigation indicated that the lift had been compromised previously in the way it was operated. What can happen is that when the lift is lowered all the way down the motor will reverse and then spool backwards. The hook mechanism spools up into the motor housing. Then the lift can get stuck in the up position. It was found that the ceiling lift was operating according to instructions. However, the possibility of the spooling backwards creates a high potential for patient harm. This is the second time there has been an incident with the ceiling lift. The point of reporting is to make others aware of the possibility of a similar event. This could be life threatening or create an incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6649533 |
| MDR Report Key | 6649533 |
| Date Received | 2017-06-19 |
| Date of Report | 2017-06-15 |
| Date of Event | 2017-02-20 |
| Report Date | 2017-06-14 |
| Date Reported to FDA | 2017-06-14 |
| Date Reported to Mfgr | 2017-06-14 |
| Date Added to Maude | 2017-06-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CEILING LIFT 625 (LIFTS UP TO 625 LBS.) |
| Generic Name | CEILING LIFT |
| Product Code | FNG |
| Date Received | 2017-06-19 |
| Model Number | 323120 |
| Catalog Number | 323120 |
| Operator | NURSE |
| Device Availability | * |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDCARE PRODUCTS |
| Manufacturer Address | 151 EAST CLIFF ROAD BURNSVILLE MN 55337 US 55337 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-19 |