MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-07-09 for HOYER POWER LIFT HPL600WBBC manufactured by Arjo Huntleigh.
[16957678]
It was reported to the manufacturer by the distributor, per the end user she was working on the day of this alleged accident she had two staff members there that witnessed the matter. She confirmed the resident has an involuntary jerking disorder and was in the hoyer lift when her lower extremities started jerking uncontrollably and she jerked her body out of the sling and fell to the floor. She confirms the hoyer lift did not break and the and the straps did not break. After the accident, she had internal maintenance guy look at the hoyer lift involved and they confirmed nothing was found defective and the unit was never taken out of service. They did not report anything to joerns as nothing found with the product, they checked out all the units in the hospital just to make sure they were in good working order and confirmed they are. The hoyer lift is still in use in their facility and did not cause this accident. The resident was taken to the hospital and sustained a vertebral compression fracture.
Patient Sequence No: 1, Text Type: D, B5
[17165666]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009402404-2015-00019 |
| MDR Report Key | 4913074 |
| Report Source | 08 |
| Date Received | 2015-07-09 |
| Date of Report | 2015-07-06 |
| Date of Event | 2015-03-01 |
| Date Facility Aware | 2015-03-01 |
| Report Date | 2015-07-06 |
| Date Reported to FDA | 2015-07-06 |
| Date Reported to Mfgr | 2015-06-30 |
| Date Mfgr Received | 2015-06-30 |
| Date Added to Maude | 2015-07-15 |
| 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 | ARJO HUNTELIGHT |
| Manufacturer Street | 2001 TANGUAY |
| Manufacturer City | MAGOG QC J1X 5Y5 |
| Manufacturer Country | CA |
| Manufacturer Postal | J1X 5Y5 |
| Manufacturer Phone | 8198680441 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOYER POWER LIFT |
| Generic Name | POWER LIFT |
| Product Code | FNG |
| Date Received | 2015-07-09 |
| Model Number | HPL600WBBC |
| Catalog Number | HPL600WBBC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJO HUNTLEIGH |
| Manufacturer Address | J1X5Y5 CA J1X 5Y5 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-07-09 |