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| Model Number MAA400M-XL |
| Device Problems
Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)
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| Patient Problems
Fall (1848); Bone Fracture(s) (1870); Injury (2348)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Additional information will be provided upon conclusions of the manufacturer's investigation.
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Event Description
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On 2018-feb-28 arjohuntleigh has become aware of an event involving maxi move passive floor lift and a maa4000m-xl clip sling, which occurred in one of the sites of (b)(6).It was reported that during resident transfer one of the clips detached from the spreader bar resulting in resident's fall.As a consequence of the fall, resident sustained an injury.However, no information was given about extent of injury and incident circumstances.
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Manufacturer Narrative
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Arjo representative contacted with the facility representative at the beginning of may.Arjo did not receive any response to the date.Collection of information is ongoing.The conclusions will be provided upon the manufacturer's investigation completion.
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Manufacturer Narrative
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We are in a process of gathering detailed information about the reported incident.The conclusions will be provided upon the manufacturer's investigation completion.
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Manufacturer Narrative
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On 2018-apr-18 it was clarified that the involved resident sustained a fractured humerus and fractured patella and subsequently died.At this time, it was not confirmed if the resident death was directly related to the reported fractures, therfore the sections collection of information is ongoing.Additional information will be provided upon conclusions of the manufacturer's investigation.
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Event Description
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On 2018-feb-28 arjohuntleigh has become aware of an event involving maxi move passive floor lift and a maa4000m-xl clip sling, which occurred in one of the sites of bupa located in wodonga or ballarat, australia.It was reported that during resident transfer one of the clips detached from the spreader bar resulting in resident's fall.As a consequence of the fall, resident sustained an injury.However, no information was given about extent of injury and incident circumstances.On 2018-apr-18 it was clarified that the involved resident sustained a fractured humerus and fractured patella and subsequently died.At this time, it was not confirmed if the resident death was directly related to the reported fractures.At the time, the facility, where the event occurred was indicated - bupa wodonga facility.
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Manufacturer Narrative
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An investigation was carried out into this complaint.Arjo became aware of an event involving maxi move passive floor lift and clip sling, which occurred in one of the sites of bupa located in wodonga, australia.It was reported that during resident's transfer one of the clips detached from the spreader bar resulting in resident's fall.The resident sustained a fractured humerus and fractured patella and subsequently died.Multiple attempts were made to contact the customer in order to obtain more detailed incident description and details surrounding resident's death.The last attempt was made on (b)(6) 2018.No other information that already received was provided.The maxi move device was not evaluated by arjo representative as the involved lift could not have been indicated by the customer.The photographic evidence of sling was provided to arjo by the customer.Based on this it was concluded that the sling was fairly new (1 year old), there was no signs of damage to the clip.The facility conducted their own root cause analysis and the results were shared with arjo.The conclusions were that the clip sling was not attached correctly to the lift and therefore the clip slipped off the attachment point when the sling was in use.The product instruction for use (ifu) is provided with each device and describes the methods of use.The ifu provides also pictographic guidance regarding proper clip attachment process.The document guides, step by step, through a proper sling application.It is important to make sure that the clip sling is attached securely before and during the lifting process.Ifu for passive clip sling warns: - "to avoid the resident from falling, make sure that the sling attachments are attached securely before or during the lifting process", - "to avoid injury to the resident, pay close attention when lowering or adjusting the spreader bar", based on the product knowledge and a simulation, when labeling is followed and the sling is placed in the correct way and the instruction of using the system is followed, it is very unlikely a resident drop or other adverse event during the transfer of the resident with the sling and lift will occur.A sling clip, once correctly attached and monitored to stay in place as the weight of the person in the sling is gradually taken up, as stated in the labeling, is locked in position with the weight of the resident.It cannot go downward as it is suspended on the clip attachment lug, and it cannot go upward because it is pulled down by the weight of the resident.When reviewing reportable complaints for maxi move registered during last 5 years with similar fault description (clip detachment), we have found a number of reportable complaints.Review of similar complaints reported in the past confirmed that this failure is only possible to occur when the labeling was not followed.To conclude, the system - clip sling and lift, was used for the resident's care.No failure with the sling, neither a malfunction within the involved lift was reported to arjo, but since the clip sling detached from the spreader bar, it can be stated that the system did not meet its performance specification.We report this event to the competent authority because of resident's fall and serious injury sustained - fractured humerus and fractured patella.The resident subsequently died.According to arjo clinical expert there is no definitive statement correlating the event with the resident's death, however, the injuries were serious and it may appear that the patient may have died as a result of this incident.
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Manufacturer Narrative
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This follow-up report is provided to correct information about patient outcome and to correct and add information to section.Initially it was reported that patient died, however after receiving communication from therapeutic goods administration (tga) regarding the incident, where tga indicated that as per their conversation with the customer, the patient is not deceased, but sustained a fractured humerus and patella, arjo contacted the bupa facility to clarify this information.In a response on (b)(6) 2018, arjo received confirmation that the patient has not passed away.It is unknown why the original informaiton provided indicated patient's death.The initial reporter who povided the original information no longer works in bupa.Regardless of the above, investigation conclusions remain unchanged.
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Search Alerts/Recalls
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