MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-26 for PATIENT LIFT 625 C-625 manufactured by Prisim Medical.
[78712513]
The patient was being transferred from w/c to bed and the lifting tape malfunctioned and suddenly released causing the patient to rapidly descend towards the floor. The lift stopped (on its own) approximately 18 inches from ground and patient was assisted safely(by staff) to bed from w/c. The patient sustained no injuries and was discharged home. The lift was taken out of service (friday) and maintenance department has been investigating to determine the root cause. A call to manufacturer has been made requesting their assistance in problem solving. On-site visit has been scheduled for (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070665 |
| MDR Report Key | 6673019 |
| Date Received | 2017-06-26 |
| Date of Report | 2017-06-26 |
| Date of Event | 2017-06-22 |
| Date Added to Maude | 2017-06-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | PATIENT LIFT 625 |
| Generic Name | 625 LIFT |
| Product Code | FNG |
| Date Received | 2017-06-26 |
| Model Number | C-625 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRISIM MEDICAL |
| Manufacturer Address | MARYLAND HEIGHTS MO 63043 US 63043 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-06-26 |