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 2020-02-21 for MAXI SKY 2 manufactured by Arjohuntleigh Magog Inc..
[188581079]
We are in a process of gathering and reviewing information regarding reported incident. Final conclusions will be provided in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[188581080]
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 | 9681684-2020-00014 |
| MDR Report Key | 9738187 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-21 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-01-29 |
| Date Added to Maude | 2020-02-21 |
| 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 2 |
| Generic Name | LIFT, PATIENT, NON-AC-POWERED |
| Product Code | FSA |
| Date Received | 2020-02-21 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-02-21 |