MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-20 for TOLLOS 60016 manufactured by Tollos, Inc..
[23564969]
Patient Sequence No: 1, Text Type: N, H10
[23564970]
The device is an overhead lift machine in the patient's room. Per nurse (rn) and patient, the rn was pushing the tollos lift to back wall to hang and the device sparked and smoked. Charge rn notified maintenance. Device was not being used for this patient. The tollos service rep performed a service evaluation on the lift. Corrective action: "checked all functions and saw no problems with lift or function. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5018032 |
| MDR Report Key | 5018032 |
| Date Received | 2015-08-20 |
| Date of Report | 2015-07-10 |
| Date of Event | 2015-07-07 |
| Report Date | 2015-07-10 |
| Date Reported to FDA | 2015-07-10 |
| Date Reported to Mfgr | 2015-07-10 |
| Date Added to Maude | 2015-08-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOLLOS |
| Generic Name | PATIENT LIFT |
| Product Code | FNG |
| Date Received | 2015-08-20 |
| Model Number | 60016 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOLLOS, INC. |
| Manufacturer Address | 1 EASTER CT STE. J OWINGS MILLS MD 21117 US 21117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-20 |