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

Model Number STRAPSTAND

Device Problem Product Quality Problem (1506)

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

Event Date 11/12/2015

Event Type  malfunction  

Manufacturer Narrative

This standing frame is just over 4 years old and was a representative sample, therefore it is assumed the unit was used quite frequently.The strap from this issue was returned and visually inspected.Upon inspection is was determined that this strap failed because the strap was not sewn all the way into the reinforced stitches on the strap.The sales representative requested an extra-large adjustable seat strap as the replacement strap for this unit and the replacement strap was shipped by altimate medical to address this issue.

Event Description

Received an email from (b)(6), an ami independent rep, that the large adjustable seat strap on his strapstand sample unit had failed and that he needed a replacement strap.The facility that was using the strapstand at the time had a user that was approximately (b)(6) lbs.And was about 45 degrees from sitting to standing when one side of the strap tore away from the body of the seat strap.The user had been sitting on a high-low mat (gym mat), therefore when the strap tore away the user was supported by the mat underneath them.No injuries to the user.

• 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 street; morton MN 56270
• Manufacturer Contact: stacey frank ; 262 west first street; morton, MN 56270 ; 5076976393
• MDR Report Key: 5286250
• MDR Text Key: 33186695
• Report Number: 2183634-2015-00006
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: STRAPSTAND
• Device Catalogue Number: 2000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 127