MAUDE Adverse Event Report: MEDIBO MEDICAL PRODUCTS NV MINERVA; LIFT, PATIENT, NON-AC-POWERED

Model Number TME.100

Device Problem Detachment Of Device Component (1104)

Patient Problems Bruise/Contusion (1754); Fall (1848); Pain (1994)

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site (b)(4).As of 2011, that number was de-activated due to the site no longer shipping product to the usa and until 2014 complaints related to these products were handled by arjohuntleigh, a branch of arjo limited med (b)(4) and any medwatch reports were submitted under registration #(b)(4).From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4)'s complaint handling establishment and any medwatch reports will be submitted under registration #(b)(4).On 12-jun-2018, an arjo representative was informed about an incident related to a minerva passive floor lift which occurred in the home de favence in (b)(6).Following the complaint's description, the problem with the chassis spreading mechanism responsible for opening and closing the device's legs was noticed during use with a patient.The tie rod (part of the chassis spreading mechanism) broke during opening the legs causing the device's legs being unable to keep the intended position.The patient got frightened and fell from the lift.As a consequence of the fall the bruises and backache developed causing that the patient needed to be transferred to the hospital.After the patient's examination, only the analgesics were recommended.No further treatment nor hospitalization was required.The system was evaluated by arjo representative who confirmed the problem with the broken tie rod.The faulty part has never been subjected to service nor repair conducted by arjo although at the time of the incident, the involved floor lift was over 16 years old.It was also impossible to verify if the maintenance was performed regularly as no maintenance records were made available to arjo because the customer did not have any service contract with arjo.The instruction for use dedicated to the minerva lift (ifu med22607 rev.0) clearly indicates how properly use the device.According to ifu, the lift should be inspected yearly by the supplier and the preventive maintenance procedure should be followed at the intervals described.The service and technical support are essential to provide the optimal protection and performance of the floor lift.There is a very low possibility of any potentially risky situation to occur if the device's owner follows every guideline given in the device ifu and regularly servicing the device.When reviewing similar reportable events for minerva (and the similar) minstrel devices, we have found a limited number of cases that may relate to the reported issue.The arjo device played a role in the event as it was used with a resident at the time of the event.There was a leg's spreading mechanism deficiency found and from that perspective, the system was not up to the manufacturer specification at the time of the incident.We find this complaint to be reportable to the competent authorities due the fact that fall from the device may pose a potentially risky situation to the resident.

Event Description

On 12-jun-2018, an arjo representative was informed about an incident related to a minerva passive floor lift which occurred in the home de favence in (b)(6).Following the complaint's description, the problem with the chassis spreading mechanism responsible for opening and closing the device's legs was noticed during use with a patient.The tie rod (part of the chassis spreading mechanism) broke during opening the legs causing the device's legs being unable to keep the intended position.The patient got frightened and fell from the lift.As a consequence of the fall the bruises and backache developed causing that the patient needed to be transferred to the hospital.After the patient's examination, only the analgesics were recommended.No further treatment nor hospitalization was required.

• Brand Name: MINERVA
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• 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, 62-05-2 ; PL 62-052
• MDR Report Key: 7644902
• MDR Text Key: 113230292
• Report Number: 3007420694-2018-00130
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: TME.100
• 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: 06/28/2018
• Distributor Facility Aware Date: 06/12/2018
• Device Age: 16 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 06/28/2018
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2002
• 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: 39 YR