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

Model Number STRAPSTAND

Device Problem Product Quality Problem (1506)

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

Event Date 03/26/2014

Event Type  malfunction  

Event Description

Received a call from a woman who purchased a strapstand in (b)(6) 2012 for her husband.She said her and a helper were putting him in the unit when one side of the strap tore away from the padded seat body of the xl adjustable seat strap on an easystand strapstand.The user was not injured but startled when it occurred.Both of them were on each side of him and he fell back into his wheelchair, which is positioned up to the standing frame, so it's available when the user goes back to the seated position.

Manufacturer Narrative

The adjustable seat strap was returned to altimate and reviewed.Upon review, it was noted that the inserted strap in the seat missed the last row of stitching.This appears to have been caused by inconsistent manufacturing processes at the supplier who manufactures these straps.Altimate medical has updated the product specifications to add add'l detailed info to the product specifications for this component and has communicated with the supplier regarding their quality control process.Altimate has also implemented a receiving inspection process on this component in addition to the current inspection process performed during the assembly and shipping process.

• 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: 3856174
• MDR Text Key: 4617498
• Report Number: 2183634-2014-00002
• 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: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: STRAPSTAND
• Device Catalogue Number: 2000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/07/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 118