MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-21 for MAXI SKY 2 manufactured by Arjohuntleigh Magog Inc..
[188483832]
It was reported to an arjo representative that there was an incident with the involvement of an arjo toilet sling and maxi sky 2 ceiling lift. Following information provided, the patient slipped out of the sling by its bottom section. Caregiver, who was present during transfer, failed to catch the patient. It seems likely that the patient slipped out due to incorrect placement in the sling. As the consequence of the event patient fell off the sling and sustained light crack to the sternum and wound at the head. Hospitalization was also required where bandage and immobilization to heal the crack were provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419652-2020-00011 |
| MDR Report Key | 9738267 |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-29 |
| Date Facility Aware | 2020-01-29 |
| Report Date | 2020-02-20 |
| Date Reported to FDA | 2020-02-20 |
| Date Reported to Mfgr | 2020-02-20 |
| Date Added to Maude | 2020-02-21 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | MAXI SKY 2 |
| Generic Name | LIFT, PATIENT, NON-AC-POWERED |
| Product Code | FSA |
| Date Received | 2020-02-21 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-02-21 |