MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O. O. MAXI TWIN COMPACT; NON-AC-POWERED PATIENT LIFT

Device Problems Detachment Of Device Component (1104); Use of Device Problem (1670)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 01/20/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusions of this investigation.

Event Description

On (b)(6) 2017 arjohuntleigh has become aware that during transfer of patient utilizing maxi twin compact passive floor lift the sling became detached from the device at the left foot end clip.The patient slipped from the sling and fell.As a consequence he fractured her knee.

Manufacturer Narrative

An investigation was carried out into this complaint.It was reported to arjohuntleigh that a resident was being transferred from a wheelchair to bathroom utilizing maxi twin compact passive floor lift.No problems with the device were noticed by caregiver.Once the bathroom door was passed, the left leg sling clip detached from spreader bar.The resident slipped from the sling - his left leg hit on the lift base (chassis).As a consequence of the event, his leg has become fractured.Therefore it is considered that a serious injury occurred as a result of the fall from the device.When reviewing similar reportable events occurred on maxi twin and maxi twin compact passive floor lifts, we have found a number of cases with similar fault description (clip detachment).If compared to the number of sold devices and in comparison to their daily usage, the occurrence rate for reportable complaints claiming this failure mode is considered to be low.No complaint trend for this particular failure mode exists.The lift as well as the sling involved were evaluated by arjohunteigh representative after the incident.No malfunction of the device was found.It was described to be "in excellent condition and functioning correctly".The sling did not present any signs of damage either - only evidence of contamination, however it did not affect its firm and stable attachment to the lift.A sling clip, once correctly attached and monitored to stay in place by caregivers 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.It cannot go inward because it is stopped by the metal frame of the spreader bar.It cannot go outward because it is stopped by the metal end stop of the clip attachment lug.It cannot go downward as it is suspended on said clip attachment lug, and it cannot go upward because it is pulled down by the weight of the patient.During the clip detachment the person is likely to fall away from the sling, towards the corner where the clip is not in place.When the clip is not attached and under tension with the weight of the person in the sling from the start, a drop will be immediate.If the labelling is followed there can be no issue.However, it is possible for the caregivers to not have followed the labelling and not checked the clips are correctly attached and remain in tension as the weight of the resident is gradually taken up.The user is obliged to monitor the clips becoming under tension when the weight of the patient is gradually being loaded on.The maxi twin compact passive floor lift instruction for use warns the user: "warning: to avoid the resident from falling, make sure that sling clips or loops are securely attached before as well as during the lifting initiation." when (a) the clip was in place and (b) it was locked in position by the weight of the person in the sling (therefore not likely to come off by itself), we have been able to establish that the only likely way to detach a clip from that situation, is that the caregiver used the strap on top of the clip - which is there to detach the clip after the transfer has ended.If doing so, when pulling the strap hard enough it can be jolted loose from the spreader bar, the resident weight will come on it and it will be very hard to hold.This scenario seems to be related to the event also, based on the event description.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.From this evaluation it would appear most likely that the event was caused by the user not following the instruction for use, due to lack of awareness of the ifu contents.Taking into account the listed above facts, it is found the device was being used for patient handling when the event occurred and it was also directly involved with the reportable incident as the sling clip detached during resident transfer contributed to the serious injury sustained by the resident.The system (lift and sling) was up to its specification at the time of the incident as no malfunction was detected.

• Brand Name: MAXI TWIN COMPACT
• Type of Device: NON-AC-POWERED PATIENT LIFT
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O. O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O. O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052 ; 98282467
• MDR Report Key: 6355893
• MDR Text Key: 68210947
• Report Number: 3007420694-2017-00041
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 03/24/2017

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?: No
• Device Operator: Other
• 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: 03/24/2017
• Distributor Facility Aware Date: 01/30/2017
• Event Location: Home
• Date Report to Manufacturer: 03/24/2017
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 02/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization