MAUDE Adverse Event Report: ARJO MEB. AB LTD. TEMPO; NON-AC-POWERED PATIENT LIFT

Model Number KPB50*

Device Problem Detachment Of Device Component (1104)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 08/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided following the conclusion of the investigation.

Event Description

On (b)(6) 2017 arjohuntleigh received customer complaint that during the resident transfer from bed to wheelchair with tempo lift and sling, leg sling clip detached from spreader bar of lift and resident slipped out of sling and fell on the floor.As a consequences resident sustained bruising on the head and back pain.

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted for the manufacturing site arjo med.Ab ltd (under registration # (b)(4) ).As of 06/15/2010, that number was de activated due to site no longer being a manufacturer and until 2014 complaints related to these products were handled by arjo hospital equipment ab and any medwatch reports were submitted under registration #(b)(4) or medibo (medibo medical products nv / 3004468271) and ah magog (arjohuntleigh magog inc./ 9681684).From 2014 and going forward complaints related to these products are to be handled by arjohunteigh ab's complaint handling establishment and any medwatch reports will be submitted under registration #(b)(4).Arjohuntleigh received customer complaint that during the resident's transfer from bed to wheelchair with tempo lift and sling, leg clip of the sling detached from the lift spreader bar.It was also indicated that the clip detachment occurred while turning the patient to the wheelchair.As a consequence, the resident fell on the floor sustaining bruise on the head and complained about back pain.Fortunately, no serious injury occurred.No medical intervention was needed.An investigation was carried out into this complaint.When reviewing similar reportable events, we have found a number of cases with similar fault description (clip detachment).No malfunctions regarding lift were reported which could have caused or contributed to the event.According to the above the lift was found to have been up to specification when the event took a place.Looking at the provided photographs evidence it can be deemed that there was no issue with the clip or pin.Both had no damages, or failure that could result in the reported event.Also there was no indication from the facility that the equipment failed in any way.It can be established the lift and sling were being used for patient handling at the time of event occurrence but it appears it contributed to the event 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 we can state following: when the sling clip is not attached and under tension with the weight of the person in the sling from the start, a drop can be immediate after not being supported by the chair.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.There are additional scenarios, that also involve use that is not following the ifu.During beginning of transfer 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.According to the instruction for use for tempo lift (kpx50550.Gb from 2003): "warning: important: always check that the sling attachment clips are fully in position before and during the commencement of the lifting cycle, and in tensions as the patients weight is gradually taken up." the labelling for the lift device indicate the system should be used by trained personnel that are aware of the ifu contents.In this case we come to the one conclusion, namely that there was a use error that caused the event.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.To conclude, clip sling and lift were used for patient's care and in this way contributed to the alleged event.No defect has been found within the clip or lift spreader bar, but since the sling clip detached from the spreader bar, it can be stated that the sling did not meet its performance specification.No serious adverse event occurred.We report this event to competent authorities as clip detachment from a spreader bar may result in serious injury if inadequate procedure of sling clip attachment would recur.

• Brand Name: TEMPO
• Type of Device: NON-AC-POWERED PATIENT LIFT
• Manufacturer (Section D): ARJO MEB. AB LTD.; st. catherine st.; gloucester, GL1 2 SL; UK GL1 2SL
• Manufacturer (Section G): ARJO MEB. AB LTD.; st. catherine st.; gloucester, GL1 2 SL; UK GL1 2SL
• Manufacturer Contact: kinga stolinska ; ul. ks. piotra wawrzyniaka 2; komorniki, 62052 ; PL 62052
• MDR Report Key: 6881918
• MDR Text Key: 88133115
• Report Number: 3007420694-2017-00196
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2017

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 Caregivers
• Device Model Number: KPB50*
• 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: 10/20/2017
• Distributor Facility Aware Date: 08/24/2017
• Device Age: 14 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 10/20/2017
• Initial Date Manufacturer Received: 08/24/2017
• Initial Date FDA Received: 09/21/2017
• Supplement Dates Manufacturer Received: 08/24/2017
• Supplement Dates FDA Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2003
• 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 Weight: 77