MAUDE Adverse Event Report: ALTIMATE MEDICAL, INC. EASYSTAND STRAPSTAND; 890.5370

Model Number STRAPSTAND

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/07/2014

Event Type  malfunction  

Event Description

Received a call from a facility that the stitching came loose on the large strap, part no.80719 on their easystand strapstand standing frame.The facility has had the unit since (b)(6) 2007 and they use the unit every day with approximately 10 different residents.The user's wheelchair is positioned up to the standing frame so it's available when the user goes back to the seated position, therefore, no injuries were reported when the stitching came loose.

Manufacturer Narrative

After discussing this issue further with the facility, it was determined that this facility has had the standing frame for approximately 7 years and uses the device on a daily basis with 10 different residents.It is assumed that the stitching came loose on this strap due to amount of time that this product has been used.The facility stated that overall the product is in good condition and that they would like two replacement straps due to the amount that this product is used.Altimate provided the facility with two replacement straps per their request.

• Brand Name: EASYSTAND STRAPSTAND
• Type of Device: 890.5370
• 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: 3748051
• MDR Text Key: 4547143
• Report Number: 2183634-2014-00001
• Device Sequence Number: 1
• Product Code: ION
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: STRAPSTAND
• Device Catalogue Number: 2000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/16/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2014
• Date Device Manufactured: 02/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1