MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. SLINGS, CLIP; NON-AC-POWERED PATIENT LIFT

Model Number MAA2090M-L

Device Problem Detachment Of Device Component (1104)

Patient Problem Fall (1848)

Event Date 05/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.Based on the information gathered, during start of the resident's transfer from bed to chair with non-arjohuntleigh ceiling lift and amputee sling, shoulder clips of the sling detached from the lugs of the lift spreader bar and the resident fell.No injuries were reported as consequences.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 relatively low and slightly decreasing.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.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.Previous simulations have established this to be at minimum over 13% of the body weight of the patient.Based on product knowledge and previously made simulations, we know that in the situation, 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 if the clips are correctly attached and remain in tension as the weight of the patient 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.This scenario is in line with the event description.The sling instruction for use (ifu) currently used contains crucial information: -"to avoid injury to the resident, pay close attention when lowering or adjusting the spreader bar." -"to avoid the resident from falling, make sure that the sling attachments are attached securely before and during the lifting process." it should be emphasized that the non-arjohuntleigh ceiling lift was used during transfer when the event occured.Amputee sling should be used together with arjohuntleigh lift devices in accordance with the allowed combinations listed in ifu.The sling instruction for use (ifu) warns: -"to avoid injury always follow the allowed combinations listed in this ifu.No other combinations are allowed." -"to avoid injury to both resident and caregiver, never modify the equipment or use incompatible parts." consequently to the above, we come to the conclusion that the event was most likely caused by use error, based on the customer information and the simulations performed previously based on earlier incidents.The labelling for the lift device indicates the system should be used by trained personnel that are aware of the ifu contents.Note that the customer was visited and interviewed by a local arjohuntleigh representative.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 03rd may 2017 arjohuntleigh received a customer complaint where it was reported that during start of the resident's transfer from bed to chair with non arjohuntleigh ceiling lift and sling, shoulder clips of the sling detached from the lugs of the lift spreader bar and the resident fell on the chair.No injuries were reported as consequences.

• Brand Name: SLINGS, CLIP
• Type of Device: NON-AC-POWERED PATIENT LIFT
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62052 ; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62052 ; PL 62052
• Manufacturer Contact: kinga stolinska ; ul. ks. piotra wawrzyniaka 2; komorniki, 62052 ; PL 62052 ; 98282467
• MDR Report Key: 6597313
• MDR Text Key: 76134443
• Report Number: 3007420694-2017-00133
• 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
• Report Date: 05/30/2017

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: MAA2090M-L
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/30/2017
• Distributor Facility Aware Date: 05/03/2017
• Device Age: 8 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 05/30/2017
• Initial Date Manufacturer Received: 05/03/2017
• Initial Date FDA Received: 05/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2016
• 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: 73 YR
• Patient Weight: 63