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

Device Problem Detachment Of Device Component (1104)

Patient Problem Fall (1848)

Event Date 07/01/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 28th april 2017, arjohuntleigh was notified that during the start of resident transfer from chair with arjohuntleigh maxi twin lift and non arjohuntleigh sling, all four sling clips began to lift off the attachment on the boom of the hoist (the top two clips to a greater degree than the bottom two).On noticing this, the service user was immediately lowered back to his chair and the trial was abandoned.No injuries were reported.

Manufacturer Narrative

(b)(4).Arjohuntleigh has been informed that during start of resident transfer from chair with tempo lift and non arjohuntliegh sling, clips of sling became detached from spreader bar of lift.On noticing this, the resident was immediately lowered back to his chair.No consequences to resident were reported.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).The trend observed for reportable complaints with this failure mode is currently considered to be low and stable.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.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: "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." it should be emphasized that non arjohuntleigh sling (glove clip sling) was involved in the event.Please note that tempo instruction for use warns: "warning only use arjo supplied slings that are designed to be used with tempo.The sling profiles illustrated (.) will help to identify the various arjo slings available." 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.From this evaluation it would appear most likely that the event was caused by the user not following the ifu.Note that the customer was visited and interviewed by a local arjohuntleigh representative.Proper lifting procedure as well as choosing sling before transfer is to be communicated to the customer.We find this complaint to be reportable to the competent authorities.

Event Description

On (b)(4) 2017, arjohuntleigh was notified that during the start of resident transfer from chair with arjohuntleigh maxi twin lift and non arjohuntleigh sling, all four sling clips began to lift off the attachment on the boom of the hoist (the top two clips to a greater degree than the bottom two).On noticing this, the service user was immediately lowered back to his chair and the trial was abandoned.No injuries were reported.On (b)(6) it was informed that tempo floor lift (not maxi twin) was involved in the event.

• 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 ; 98282467
• MDR Report Key: 6593323
• MDR Text Key: 76134163
• Report Number: 3007420694-2017-00126
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2017

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
• 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: 06/23/2017
• Distributor Facility Aware Date: 04/28/2017
• Device Age: 12 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 06/23/2017
• Initial Date Manufacturer Received: 04/28/2017
• Initial Date FDA Received: 05/26/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2005
• 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