MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. FLITES (BOXES OF 10), CLIP; LIFT, PATIENT, NON-AC-POWERED

Model Number MFA1000M-XL

Device Problem Material Separation (1562)

Patient Problem Fall (1848)

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2016 arjohuntleigh received customer complaint where it was reported that patient was being lifted from the floor in sling and one of the shoulder clip straps sheared and ripped the sling with the patient falling to the floor.As a consequences patient sustained no injury, however the spreader bar swung around due to the change in weight distribution and hit a nurse in the chest who was in close proximity to the patient reassuring her whilst being lifted.

Manufacturer Narrative

(b)(4).The device was requested for return to the manufacturing site in order to perform further evaluation of claimed sling.Additional information will be provided following the conclusion of the investigation.

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.Based on the information received it was indicated that the hoist and the arjohuntleigh disposable "flite" sling was used to lift the patient off the floor.The information regarding what type of medical device was involved in this event was not disclosed.During starting the lifting process of the resident from the floor when resident was approximately couple inches from floor, the patient fell.Resident sustained no injury, however the spreader bar swung around due to the change in weight distribution and hit a nurse in the chest who was in close proximity to the patient reassuring her whilst being lifted."pain" was reported as consequences.No medical nor surgical intervention was required.When reviewing similar reportable events, we have found a number of cases with similar fault description.The trend observed for reportable complaints with this failure mode is currently considered to be low.The sling was inspected by arjohuntleigh representative after becoming aware of the incident.It was indicated that sling appeared to have torn along stitching causing sling strap to detach.According to the above the sling and the lift which work together as a system were found to have been not in accordance to the specification when the event took a place.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.The model number of the disposable sling - flite involved in the incident is mfa1000m-xl.The sling was requested for return to the manufacturing site in order to perform further evaluation, however has not been returned.Based on the product knowledge and previous simulations, it is highly unlikely that the strap of disposable "flite" sling will become ripped from the main body of the sling (both - shoulder and leg straps) during on-label use.According to the instruction for use (ifu) (04.Sc.00-int1_2) arjohuntleigh recommends to perform the 6-step inspection of the sling before first use as well as 7-step inspection before every use.Both of these procedures include the information that the inspection of all parts of the sling should be performed prior to each use with the patient to ensure that use of the product is safe.If the caregivers could not follow the ifu and the inspection could be performed not carefully enough, it is possible that some placement errors - like pinching the sling under the shoulder by something prior to raising the patient - could remain unnoticed.According to the lifting procedure described in the ifu the appropriate position of the lift towards the patient as well as proper positioning of the spreader bar needs to be achieved.Afterwards, the leg flaps need to be checked if not twisted and the shoulder clips need to be attached to the spreader bar.Then, the resident's head needs to be slightly lifted and the floor lift is repositioned closer towards the legs of the patient.Ensuring that the brakes are locked, the leg clips need to be attached and the tension in the sling is created by slightly lifting the resident.Afterwards, the inspection of the attachments and the patient comfort needs to be performed prior to lifting patient.If the adjustment is needed, it is necessary to lower the patient and perform appropriate corrections.If the patient is positioned correctly, the brakes can be released and the transfer can be initiated.Not following the instructions of appropriate attachment of the sling to the spreader bar can also result in the device failing in the similar way as described in the complaint.If the straps or leg flaps are twisted after the attachment to the lift and it is not noticed by the caregiver, it can result in occurrence of the excessive tension in the straps.If the step regarding checking the connections after slightly lifting the sling to create tension is omitted, some crucial errors can remain unnoticed.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.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 in abundance of caution.

• Brand Name: FLITES (BOXES OF 10), CLIP
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, PL-62 052; PL PL-62052
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki,, TX 62-05-2 ; PL 62-052 ; 2103170412
• MDR Report Key: 6137468
• MDR Text Key: 61300976
• Report Number: 3007420694-2016-00242
• 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,Followup
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: MFA1000M-XL
• Device Lot Number: D11151201917
• 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: 03/31/2017
• Distributor Facility Aware Date: 11/02/2016
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2017
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2015
• 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: 65 YR
• Patient Weight: 50