MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-06 for HOYER LIFT HPL-600 manufactured by Sunrise Medical.
[113510862]
Reporter states that a resident at approx 15:40 was transferred via hoyer lift by two employees with one standing in front of resident and the second employee behind the resident. Per reporter, while in the process of transferring resident from wheel chair to bed, the strap protecting the resident's left shoulder got loose causing the resident to fall off of the sling to the floor. Resident complained of headache and neck pain and was transferred to the er for evaluation and treatment. According to reporter, upon further evaluation, a c2 fracture was observed and resident was then admitted. Per reporter, the right sling was used as there was no defect (tear/hole) noted and did pass functionality test. The lift and sling were removed from service, pending evaluation from mfr. Reporter states that management notified mfr of the incident on (b)(6) 2018 and want fda to also be informed as well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078282 |
| MDR Report Key | 7670764 |
| Date Received | 2018-07-06 |
| Date of Report | 2018-07-06 |
| Date of Event | 2018-06-15 |
| Date Added to Maude | 2018-07-09 |
| 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 | RISK MANAGER |
| 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 | HOYER LIFT |
| Generic Name | PATIENT LIFT |
| Product Code | FNG |
| Date Received | 2018-07-06 |
| Model Number | HPL-600 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNRISE MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-06 |