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

Model Number STRAPSTAND

Device Problem Inadequate or Insufficient Training (1643)

Patient Problems Bone Fracture(s) (1870); Hematoma (1884)

Event Date 03/26/2019

Event Type  Injury  

Manufacturer Narrative

Altimate medical (ami) contacted the independent rep in the area and he agreed to go to the facility to review the unit, go over how to properly use the unit and add the accessories determined to be needed based on the conversation with the faciltiy.Ami then shipped the rep the swing-out leg option, foot straps and upper body support strap.Ami's independent rep went to the facility on 4/17/2019 to add the additional parts and to provide training on the proper use of the unit.Notes from the rep's visit are as follows: the therapy group that works with the facility verified to the rep that when this client's wheelchair did not fit between the standard legs ordered on the unit, that 3 people tried to place the client in the unit.One person on each side of the client and one that tried to position the strap under the client.By doing this the strap was not positioned correctly, which is what caused this to occur.In addition, the owner's manual includes instructions for use which state to position the client's wheelchair as close as possible up to the knee pad on the stander.The instructions also state that the wheelchair should remain in position so it's available for the client to return to the seated position.Photos showing this are also included in the instructions for use.Ami's independent rep added the swing-out legs and the straps that were shipped for the unit and trained the staff on how to use the unit.During the training the group was split into 4 groups; the rep went through the product with them and had them each try using the product on each other.After the training the facility had the rep sign off on a training sheet.The facility also requested an additional lifting strap, part no.82207, adjustable sling strap, which was provided at no charge.The rep also discussed with them that they should have a local medical equipment dealer to work with if any parts and/or service is needed in the future.It is determined that this occurred due to: the unit being ordered without the correct accessories and failure to follow the instructions for use.When it was noted that the wheelchair did not wheel up to the stander as in the instructions and photos in the owner's manual, the unit should no longer have been tried to be used and the facility's medical equipment supplier or altimate medical customer service should have been contacted.During the initial conversation with the contact at the facility, it was verified that they received an owner's manual.The owner's manual includes instructions and photos on how to use the easystand strapstand.

Event Description

Received a phone call from a facility stating that a client had fallen back in a strapstand.The product serial number was provided and the unit reviewed.The product that was ordered by the facility was a basic strapstand.Various questions were asked to obtain more information, and the following information was obtained: the client fell back "like you would fall back in a swing" with buttocks in the sling and back of head hitting the floor.When standing the strap slid down.When asked if the wheelchair was positioned underneath the client, she said no, because when the wheelchair was wheeled up to the stander it did not fit in between the legs of the unit.I informed her that due to different wheelchair widths, there are standard legs and swing away legs and that the standard legs were what was ordered.She said when the wheelchair didn't go in between the legs of the unit that 3 of them tried to put the client in the stander, by having one person on each side of him and one person putting on the strap.The contact was asked if they saw an inservice of the product or if the unit was spec'd out before ordering and she said no they just ordered it out of a catalog.The contact was also asked if they received an owner's manual and she said yes.Informed the contact that i would get in touch with our independent representative in the area and see if he could come to the facility to show them how to use the strapstand and bring out some additional options for the product.

• Brand Name: EASYSTAND STRAPSTAND
• 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 st; morton MN 56270
• Manufacturer Contact: stacey frank ; 262 west first street; morton, MN 56270 ; 5076976393
• MDR Report Key: 8551437
• MDR Text Key: 143235588
• Report Number: 2183634-2019-00001
• Device Sequence Number: 1
• Product Code: ION
• UDI-Device Identifier: 10858921006086
• UDI-Public: (01)10858921006086
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K885343
• 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: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: STRAPSTAND
• Device Catalogue Number: 2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/04/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 74