MAUDE Adverse Event Report: ALTIMATE MEDICAL EASYSTAND EVOLV; STANDING FRAME

Model Number EVOLV LARGE

Device Problem Device Handling Problem (3265)

Patient Problem Multiple Fractures (4519)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

Ami was made aware of an incident in the (b)(6) by our international sales rep where a patient broke their leg above the knee and ankle while using an evolv large.The patient was placed in the unit by the caregiver in front of a mirror with lights.The caregiver then walked away from the patient.When the patient was left alone they partially fell out of the unit which caused the patient to break their right leg above the knee and ankle.This patient has cerebral palsy and epilepsy.Personnel should be trained by the facility on the equipment they are using along with which type of clients they are putting in the equipment and their diagnosis.Altimate medical provides instructions for use with each product which includes how to properly use and adjust the unit.Stated in the instructions for use (product owner's manual) on page 1 paragraph 8: the easystand evolv must be used with a qualified adult attendant present.In addition, stated in the instructions for use on page 2 bullet 8: ensure the necessary support and alignment options are in position prior to bringing the user into the standing position.The way to properly fit and adjust the standing frame to the user is listed on page 35 of the instructions for use and also on a fit guide tag that is attached to the unit.The unit was inspected by 2 different technicians, one from the distributor and one from the dealer and did not find any issues with the unit.Training will be provided to the staff of the facility by the dealer to address the lack of training the staff received.

Event Description

Evaluation easystand evolv large following incident on (b)(6) 2020.Serial number: (b)(4).Diagnosis: cp, epilepsy.The client broke her right leg on two places.Technically, the standing table has been checked and all settings can be properly fixed.There is no technical problem, or wear and tear to be discovered on the standing table, which would prevent certain parts from being fixed.Everything works as it should.Spoken with the manager and one of the employees who took the client out of the standing table, but it is not possible for me to find out what exactly happened.The employee reports that she put the client in the standing table in front of the mirror with lights.Then walked away for a while, when she came back the whole standing table had turned a quarter turn and the worktop was "gone".The client was completely under the seat.In the panic to get the client out of the standing table as quickly as possible, all settings were of course changed and it was also not clear from the story how, for example, knee supports or worktop stood.She indicates that she has checked everything but, for example, the knee supports are set to a certain depth and she said she never touched it.It is therefore unclear whether these have really been fixed.After this, the standing table was also viewed technically by the atlas technician, so settings as they were during the incident cannot be traced back to me.Because the settings can no longer be traced, and it is not clear what the settings were like after the incident, it is not possible to trace what happened.Recommendation: when the standing table is to be used again, settings must be made again with ergo and / or physiotherapist and employee of anatomic sitt and / or atlas kidtech.Then check again whether there is somewhere the possibility to get out of the standing table if everything is properly fixed.Instruction to all employees about using the standing table.

• Brand Name: EASYSTAND EVOLV
• Type of Device: STANDING FRAME
• Manufacturer (Section D): ALTIMATE MEDICAL; 262 west first st.; morton MN 56270
• Manufacturer (Section G): ALTIMATE MEDICAL INC.; 262 west first street; morton MN 56270
• Manufacturer Contact: travis fluck ; 262 west first street; morton, MN 56270 ; 5076976393
• MDR Report Key: 11059396
• MDR Text Key: 224028886
• Report Number: 2183634-2020-00003
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 10858921006017
• UDI-Public: (01)10858921006017
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K062402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: EVOLV LARGE
• Device Catalogue Number: PNG50084
• Date Manufacturer Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/08/2017
• 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): Required Intervention