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 2020-02-10 for MAXI 500 KM560181 manufactured by Arjohuntleigh Magog Inc..
[178336722]
Collecting information is still ongoing. Arjo is trying to determine what were the event circumstances, what was the patient health outcome and whether the patient's death was a direct result of reported incident. Additional information will be provided upon investigation conclusions.
Patient Sequence No: 1, Text Type: N, H10
[178336723]
It was reported to an arjo representative that there was an incident with the involvement of maxi 500 floor lift and passive clip sling. Following initial information provided, it seems likely that during transfer one of the sling's clip detached from a spreader bar attachment point (pin) causing the resident to fall off the sling. Referring to the information provided by the customer, the event was the most probably a result of an user error resulting from the transfer being carried out by two staff members from another company. On (b)(6) 2020 the customer has been visited by the arjo representative to perform interview and device evaluation. There were no abnormalities found within the lift nor the sling. However, arjo was informed that patient involved in the event passed away. It still remains unknown what were the event detailed circumstances and what was the cause of the patient's death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681684-2020-00010 |
| MDR Report Key | 9686067 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-10 |
| Date of Report | 2020-03-11 |
| Date Mfgr Received | 2020-01-14 |
| Device Manufacturer Date | 2015-08-20 |
| Date Added to Maude | 2020-02-10 |
| 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 500 |
| Generic Name | LIFT, PATIENT, NON-AC-POWERED |
| Product Code | FSA |
| Date Received | 2020-02-10 |
| Model Number | KM560181 |
| 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. Death | 2020-02-10 |