MAUDE Adverse Event Report: MEDIBO MEDICAL PRODUCTS NV ENCORE

Device Problems Inadequate or Insufficient Training (1643); Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/25/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Arjohuntleigh has become aware of the customer complaint indicating that at as a consequence of lifting procedure, using the encore lift, the resident received a serious injury described as: 'some sort of fracture'.No further information have been revealed so far therefore arjohuntleigh will be trying to obtain additional information relating to this particular complaint.We will provide a follow-up report based on details we will receive.

Manufacturer Narrative

(b)(4).An investigation was performed based on the gathered complaint information.When reviewing similar reportable events for encore and similar devices, we have found a low number of cases related to the failure: patient not suited for use with the device - note that this was the only relevant issue found according to the investigation findings.The occurrence rate of reportable complaints with this fault description is relatively low.Please note that the encore is an active resident lift.This means that the patient is intended to have an active participation in the transfer process - from raising the patient to the standing position to the transfer with the lift.In other words, the intended user group as indicated in the device labelling, is mentally and physically capable of at least partial standing capability and stability.After the event, the device was put through a function test and no deviation was observed - the device was in full working order.According to that, this event does not appear to have been caused by lift or sling malfunction.All collected facts bring us to the conclusion that the patient was not properly assessed before transfer.The involved staff may not have been aware the requirement of the professional assessment of the patient before transfer as indicated in the instruction for use (ifu), which in turn makes it unlikely the professional judgment of the patient was taken into account before use.Our evaluation appears to be in line with a use error having occurred.Our assumption is that the facility staff does not understand the importance of the patient assessment which should be carried out by a qualified nurse or therapist before lifting process.In the labelling there is a particular attention to the responsibility of the device owner to make sure that the device users are trained and knowledgeable of the contents of the labelling.This is to be communicated to the customer facility staff responsible for conducting the professional patient assessment.Based on the above, arjohuntleigh assumption is that the facility staff was not aware about the importance of the professional patient assessment, which should be carried out by a qualified nurse or therapist, before lifting process.In the labelling there is a particular attention to the responsibility of the device owner to make sure that the device users are trained and knowledgeable of the contents of the labelling.In summary, the device was being used at the time of the event and played a role in the reported incident.There was no device deficiency found and from that perspective the system was up to specification at the time of the incident.When the ifu would have been followed and the professional assessment of the patient before transfer would be provided before transfer, the event would have been avoided.This is to be communicated to the customer.We find this complaint to be reportable to the competent authorities.

Event Description

Following the information collected upon the course of the investigation, at the time of lifting the resident from the bed to the wheelchair, using the encore standing hoist, the resident was reported to became weak, lost her grip and as a consequence slid down the floor.Another passive lift was used to transfer resident back to bed.After the issue, the resident was dispatched to the hospital.

• Brand Name: ENCORE
• Type of Device: ENCORE
• Manufacturer (Section D): MEDIBO MEDICAL PRODUCTS NV; heikant 5; hamont-achel, BE-39 30; BE BE-3930
• Manufacturer (Section G): MEDIBO MEDICAL PRODUCTS NV; heikant 5; hamont-achel, BE-39 30; BE BE-3930
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki,, TX 62-05-2 ; PL 62-052 ; 2103170412
• MDR Report Key: 6048171
• MDR Text Key: 58130683
• Report Number: 3007420694-2016-00222
• 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
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 01/20/2017,09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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: 01/20/2017
• Distributor Facility Aware Date: 09/22/2016
• Device Age: 13 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 01/20/2017
• Initial Date Manufacturer Received: 09/22/2016
• Initial Date FDA Received: 10/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2003
• 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 Age: 78 YR