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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIBO MEDICAL PRODUCTS NV ENCORE

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MEDIBO MEDICAL PRODUCTS NV ENCORE Back to Search Results
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.
 
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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 Key6048171
MDR Text Key58130683
Report Number3007420694-2016-00222
Device Sequence Number1
Product Code FSA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 FDA01/20/2017
Distributor Facility Aware Date09/22/2016
Device Age13 YR
Event Location Nursing Home
Date Report to Manufacturer01/20/2017
Initial Date Manufacturer Received 09/22/2016
Initial Date FDA Received10/21/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/11/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age78 YR
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