MAUDE Adverse Event Report: MORTARA INSTRUMENT, INC. TMX425; TREADMILL

Model Number FVMILL-AAA-EABAB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Loss of Range of Motion (2032); Discomfort (2330); Fracture, Arm (2351); Arthralgia (2355)

Event Date 07/29/2016

Event Type  Injury  

Manufacturer Narrative

There was no allegation of malfunction.The patient was on the treadmill and when the stage changed at 4 min, the patient fell on her left side.She sustained injuries to her left shoulder and left knee which have left her with loss of motion and pain in the left shoulder and discomfort in the left knee.The patient was seriously injured as defined by fda due to permanent injury.This treadmill is intended to be used during stress testing.It is equipped with an emergency stop button for the patient as well as can be stopped by the clinician using the stress system that is controlling it.Furthermore, standard of care dictates that exercise stress tests on treadmills are closely supervised.

Event Description

Mortara instrument received a report from the account stating a patient fell during an exercise stress test from the treadmill.The treadmill was located at the account.The complaint was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: TMX425
• Type of Device: TREADMILL
• Manufacturer (Section D): MORTARA INSTRUMENT, INC.; 7865 n. 86th street; milwaukee WI 53224
• Manufacturer (Section G): MORTARA INSTRUMENT, INC.; WI
• Manufacturer Contact: 3017 full vision dr; newton, KS 67114 ; 3162833344
• MDR Report Key: 7506529
• MDR Text Key: 107992555
• Report Number: 2183461-2018-00001
• Device Sequence Number: 1
• Product Code: IOL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,user facilit
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: FVMILL-AAA-EABAB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 69 YR
• Patient Weight: 77