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 2020-03-18 for MAXI SKY 440 LE00000-EUUK manufactured by Arjohuntleigh Magog Inc..
[188405579]
Arjo qualified representative visited the customer facility after the event to perform device evaluation. No malfunction was found within maxi sky 440 ceiling lift or its spreader bar. At the time of the event, the ceiling lift was used with the loop sling manufactured by a third party company, (b)(4). Based on a product brochure available on the manufacturer? S website, this was? Standard hammock sling, comfort model? , size m. Looking at the construction, it is 4-loop model and in the brochure it is presented with 4-point spreader bar. Arjo maxi sky 440 ceiling lift is equipped with 2-point spreader bar and it is unknown how the sling works with the spreader bar with different geometry. The maxi sky 440 instructions for use (ifu, document number 001. 16000. 33. Rev. 6 dated on february 2010) warns that only parts designated by arjohuntleigh should be used on products supplied by arjohuntleigh. (b)(4) sling was not authorized for use with maxi sky 440 ceiling lift. Furthermore, according the caregiver, he thought he attached the sling incorrectly to the spreader bar. Maxi sky 440 instructions for use includes transferring procedure and informs the user how to attach the sling properly. To sum up, incorrect transfer procedure performed by the caregiver is considered to be a direct root cause of the patient? S fall and sustained serious injury. Using non-authorized sling in combination with arjo ceiling device is against maxi sky 440 instructions for use and might be a contributing factor. Review of reportable complaints registered within the last 5 years revealed that there was no other case where non-arjo sling detached during resident? S transfer with maxi sky 440 ceiling lift. Therefore we consider this complaint to be an isolated occurrence. The maxi sky 440 ceiling lift in combination with non-authorized loop sling was used as a system for transferring the resident and played a role in the reported event. The evaluation of arjo maxi sky 440 shown no technical deficiency within the device, however the sling loop detached during use and from that perspective system did not work as intended. The complaint was decided to be reportable to competent authorities due to reported patient's fall from arjo device and sustained serious injury.
Patient Sequence No: 1, Text Type: N, H10
[188405580]
On (b)(6) 2020 arjo was informed about event that took place in facility in (b)(6). Following information provided, the patient fell during transfer from the chair to the bed, using arjo maxi sky 440 ceiling lift and non arjo sling. In effect, the resident sustained tibial fracture, unstitched forehead laceration and facial bruise. The caregiver, who assisted the resident during transfer, said that he could have attached the sling incorrectly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681684-2020-00021 |
| MDR Report Key | 9846531 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2010-06-29 |
| Date Added to Maude | 2020-03-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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, QUEBEC J1X 5Y5 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | J1X 5Y5 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAXI SKY 440 |
| Generic Name | LIFT, PATIENT, NON-AC-POWERED |
| Product Code | FSA |
| Date Received | 2020-03-18 |
| Model Number | LE00000-EUUK |
| Device Availability | Y |
| 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 | 2020-03-18 |