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

Model Number STRAPSTAND

Device Problems Unintended System Motion (1430); Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

In the picture provided by the distributor, the bolts for the pump linkage were missing, which is what caused this to occur.In addition, the estimated life of the strapstand is 5 years.This unit was orginally shipped in january 2008 making this unit almost 12 years old.Ami personnel contacted the distributor on several occasions asking for additional information regarding the caregiver and for more pictures of the entire unit.However, we have been unable to receive any additional information, which leads us to believe the injury was not serious.The instructions for use provided with the strapstand stated to check your strapstand periodically to make sure that all nuts, bolts, and adjustable parts are tightened securely.In the last email sent to the distributor ami reminded the distributor of the following information: keep the client's wheelchair in position while they are standing in the strapstand.Inspect the strapstand daily to ensure that all nuts, bolts, and adjustable parts are tightened securely.Inspect the (seat) strap of the strapstand daily.If you see any wear on any components contact altimate medical customer service.

Event Description

Received an email from a distributor along with a picture informing us that the bolts in the pump linkage used to raise the lifting arms on an easystand strapstand came out and the patient started to descend.When the patient started to descend the caregiver caught the patient.The distributor informed us that the caregiver's waist was hurt when this occurred.

• 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: travis fluck ; 262 west first street; morton, MN 56270 ; 5076976393
• MDR Report Key: 9235232
• MDR Text Key: 217332856
• Report Number: 2183634-2019-00002
• Device Sequence Number: 1
• Product Code: ION
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K885343
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: STRAPSTAND
• Device Catalogue Number: 2000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/07/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 60