MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB MAXI TWIN; NON-AC-POWERED PATIENT LIFT

Model Number KTBB4BSX2EU

Device Problem Detachment Of Device Component (1104)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 08/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.Based on the information received it was indicated that during the patient's transfer from bed to wheelchair with using maxi twin lift and sling, right clip of the sling detached from the lug of the lift spreader bar and the resident fell on the floor.Resident sustained a head laceration required medical intervention as a consequence of the event.When reviewing similar reportable events, we have found a number of cases with similar fault description (clip detachment).The trend observed for reportable complaints with this failure mode is currently considered to be low and stable.The maxi twin lift as well as sling was inspected, no malfunctions were found that could have caused or contributed to the event.It can be established that the sling and the lift were being used for patient handling but it appears it contributed to the event possibly due to a use error.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 indicated to be required in the labelling, is locked in position with the weight of the patient.It is not likely to come off during on label use.Based on product knowledge and previously made simulations this then leaves open a possible sequences of events: 1) following all details reported the patient was lifted from the bed, therefore from the horizontal position.From simulations, we know that a person can be lifted from a horizontal position with one of the leg clips not in place.However, typically when the patient is at the end of that transfer, put into a more upright, seated position before lowering to a wheelchair, the weight shifts towards the missing clip strap and the person falls out.Following the above scenario, it would appear possible that one of the clips was not in place at the start of the lifting procedure (it could have become wiggled off before being lifted from bed) and when the weight would shift as the patient was put into a more upright, vertical position the person would slide out.2) there are additional scenarios that also represent using our device against product labeling and ifu: when a transfer occurs from a bed, this means at some point there must be a repositioning from horizontal to seated position.This then means that the resident must be turned in the correct direction.As a result the caregiver must manipulate the spreader bar that holds the sling and is able to turn for this purpose.The intended and labelled use is that this occurs by operating and manipulating the spreader bar itself, and not the sling nor the person in the sling.If this labelling is followed there can be no issue.However, it is possible for the caregiver to not have followed the labelling and have used the person in the sling to manipulate the spreader bar.In this case the clip could be inadvertently pulled off by the caregiver while using the sling or the person in the sling for repositioning.The maxi twin lift ifu (04.Kt.00) includes information about safe and correct use of the product: "warning: important always check that the sling attachments clips are fully in position before and during the commencement of the lifting cycle, and in tension as the patient's weight is gradually taken up." finally, the labelling for the lift device and sling indicate the system should be used by trained personnel that are aware of the ifu contents.We come to the one conclusion, namely that there was a use error that caused the event.No technical malfunctions were reported regarding the lift (maxi twin) and the sling which work as a system.Nevertheless, the clip was reported to detach (in our evaluation was caused by the user not following the ifu) and from that perspective, the system did not meet its performance specification.Arjohuntleigh suggests to remind the staff involved of the device labelling, with special attention to correct lifting procedure.This is to be communicated to the customer.We find this complaint to be reportable to the competent authorities.

Event Description

On (b)(6) august 2017 arjohuntleigh received a customer complaint where it was indicated that during the patient's transfer from bed to wheelchair with maxi twin lift and sling, right leg clip of the sling detached from spreader bar of lift causing the patient fall to the floor.As a consequence of the event the patient sustained a head laceration.The stitches were required to close the wound.

• Brand Name: MAXI TWIN
• Type of Device: NON-AC-POWERED PATIENT LIFT
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• Manufacturer Contact: kinga stolinska ; ul. ks. piotra wawrzyniaka 2; komorniki, 62052 ; PL 62052
• MDR Report Key: 6840712
• MDR Text Key: 84635716
• Report Number: 3007420694-2017-00181
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 09/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: KTBB4BSX2EU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/03/2017
• Distributor Facility Aware Date: 08/07/2017
• Device Age: 9 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/03/2017
• Initial Date Manufacturer Received: 08/07/2017
• Initial Date FDA Received: 09/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 93 YR
• Patient Weight: 51