MAUDE Adverse Event Report: ALTIMATE MEDICAL, INC. EASYSTAND EVOLV; 890.3110

Model Number EVOLV MEDIUM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 01/06/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, altimate medical (ami) customer svc received a call from a facility regarding a broken thread on a caster.The following add'l info was obtained on (b)(6) 2015 from the facility: the thread on one of the back casters broke and the back end of the frame went down to the floor., causing the stander to be uneven.The teacher saw this and helped the child in the unit lay on the floor.Help arrived and three people then stood the stander back up and two more lifted the child out of the stander.The nursing staff at this facility checked over the child and he appeared to be ok, however, the parent of the child wanted him taken to the emergency room by ambulance to be further checked out.On (b)(6) 2015 attempts were made to gather further info but the facility was unable to provide any further info at the time.

Manufacturer Narrative

On f/u attempts to obtain add'l info, the facility has been unable to provide add'l info at this time.However, the facility stated they will keep in contact with ami and let us know when they can provide add'l info.In addition, ami has requested to have the caster and the base returned so this issue can be investigated.The facility is unable to return the components at this time but stated it will f/u with ami if and/or when they can return the components to ami.

• Brand Name: EASYSTAND EVOLV
• Type of Device: 890.3110
• Manufacturer (Section D): ALTIMATE MEDICAL, INC.; 262 west first st.; morton MN 56270
• Manufacturer Contact: stacey frank ; 262 west first st.; morton, MN 56270 ; 5076976393
• MDR Report Key: 4490879
• MDR Text Key: 15321426
• Report Number: 2183634-2015-00001
• Device Sequence Number: 1
• Product Code: ION
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EVOLV MEDIUM
• Device Catalogue Number: NG50162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2012
• 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