MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-02-13 for MAXI SKY 600 LD10000 manufactured by Arjohuntleigh Magog Inc..
[187017758]
We are in a process of reviewing information gathered. Additional information will be provided upon investigation conclusions.
Patient Sequence No: 1, Text Type: N, H10
[187017759]
It was reported to an arjo representative that there was an incident with the involvement of maxi sky 600 and passive clip sling. It was stated that at the initial phase of patient's transfer, when resident was lifted out of the bed, right leg clip detached from the spreader bar attachment point. Following information provided, the patient was restless and in a state of opposition during the lifting procedure. As the consequence of the event the resident fell off the sling and sustained femur fracture and ecchymosis on the left eyebrow.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681684-2020-00012 |
| MDR Report Key | 9705313 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-13 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-01-25 |
| Date Mfgr Received | 2020-02-06 |
| Device Manufacturer Date | 2006-11-07 |
| Date Added to Maude | 2020-02-13 |
| 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 | KINGA STOLINSKA |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| Manufacturer Phone | 688282467 |
| Manufacturer G1 | ARJOHUNTLEIGH MAGOG INC. |
| Manufacturer Street | 2001 TANGUAY STREET |
| Manufacturer City | MAGOG J1X5Y5 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | J1X5Y5 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAXI SKY 600 |
| Generic Name | LIFT, PATIENT, NON-AC-POWERED |
| Product Code | FSA |
| Date Received | 2020-02-13 |
| Model Number | LD10000 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH MAGOG INC. |
| Manufacturer Address | 2001 TANGUAY STREET MAGOG, QUEBEC J1X 5Y5 CA J1X 5Y5 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-13 |