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

Model Number KMBB4ESU2FUS

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusions of the manufacturer's investigation.

Event Description

Arjohuntleigh has become aware that during a resident transfer utilizing maxi move passive floor lift, one of resident's leg slipped out of sling and was lowered to the floor with no injuries.

Manufacturer Narrative

An investigation was carried out into this complaint.It was reported that during transfer of resident (female, (b)(6)) utilizing the maxi move passive floor lift one of four sling clips detached from spreader bar.As a consequence, one of resident's leg slipped out of sling.Immediately after the event, the assisting caregiver lowered the resident safely to the floor without any injuries.When reviewing similar reportable events occurred on maxi move 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.The involved lift and sling were inspected after the incident by arjohuntleigh representative.The lift was found in general good working condition, however its spreader bar was wrapped with form and black tape.One of the sling's clips was slightly bent.The device was not under arjohuntleigh service/maintenance contract.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.The instruction for use for maxi move lift warns (04.Km.00): "important: always check that all the sling attachment 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." during the clip detachment, the person is likely to fall away or slip out of the sling, towards the corner where the clip is not in place.In this particular case, one resident's leg slipped out from the sling what clearly indicates that the lower (leg) clip came off.The spreader bar used with the device was wrapped with unapproved padding and black tape causing an impact on clip attachment lug on which the sling clip is attached on.Such unauthorized alternation to the product could have impacted also on shape of the clip and bent it slightly as reported by our representative.This, as a consequence could have contributed to the reported outcome - clip slipping out of the lug.Please note that the labeling of the maxi move warns the user: "arjo strongly advise and warn that only arjo designed parts, which are designed for the purpose, should be used on equipment and other appliances supplied by arjo, to avoid injuries attributable to the use of inadequate parts.Unauthorized modifications on any arjo equipment may affect its safety.Arjo will not be held responsible for any accidents, incidents or lack of performance that occur as a result of any unauthorized modification to its products." from this evaluation it would appear most likely that the event was caused by the user not following the ifu, due to lack of awareness of the ifu contents.Arjohuntleigh suggests reminding the staff involved of the device labelling, with special attention to correct lifting procedure and risk associated with any unapproved modification of the device.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.Due to unapproved modification of the spreader bar by the customer facility, the device was not up to its specification at the time of the incident.

• Brand Name: MAXI MOVE
• 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 ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052 ; 98282467
• MDR Report Key: 6355912
• MDR Text Key: 68229574
• Report Number: 3007420694-2017-00042
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: KMBB4ESU2FUS
• 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: 03/17/2017
• Distributor Facility Aware Date: 02/02/2017
• Device Age: 11 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 03/17/2017
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 02/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2006
• 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): Other
• Patient Age: 51 YR
• Patient Weight: 56