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

Model Number EVOLV LARGE

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2022

Event Type  malfunction  

Manufacturer Narrative

The device history record for the stander was reviewed.The device is more than 2 years past its estimated life.There have been no issues/complaints previously recorded for the device since its manufacture in 2015.Included in the safety precautions section of the products owners manual that is sent with every device states: if the easystand is used in the home environment, please inspect the unit prior to each use to ensure there is no damage or unexpected wear to the easystand that may have been caused unintentionally by pets, pests, and children.Also stated: the expected service life of an easystand is considered 5 years under normal use conditions.In addition there is a hydraulic actuator maintenance section in the products owners manual which states the following: hydraulic actuator maintenance: if the pump is leaking oil or not holding properly contact your local easystand supplier for a replacement, the serial number on the easystand will be needed.Do not exert excessive force on the pump handle or use the pump handle to move an easystand this may cause damage to the pump handle and/or the pump mechanism and will void any warranty.User maintenance is not required or recommended on the hydraulic pump.Never apply lubricant, household oil, grease, or a similar product to any part of the unit.Some compounds may react with the seals used in the manufacture of this product.This may damage the unit and will void any warranty.The distributor has replaced the unit for the customer with a new standing aid.

Event Description

On 12/1/2022, altimate medical received a notice from the distributor in sweden there was an issue reported to the swedish authority.The report was sent to altimate medical in swedish and google translate was used to translate the report.The report entry translated as: "sequence of events - the patient was going to stand exercise in his easystand, with the help of an assistant, when the piston broke (according to the description "exploded") and oil leaked out.Fortunately, no one was physically harmed.

• Brand Name: EASYSTAND EVOLV
• Type of Device: STANDING FRAME
• Manufacturer (Section D): ALTIMATE MEDICAL, INC.; 262 west first street; 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: 16062714
• MDR Text Key: 306824090
• Report Number: 2183634-2022-00003
• Device Sequence Number: 1
• Product Code: INO
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K062402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EVOLV LARGE
• Device Catalogue Number: PNG50084
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1