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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CRITIKON DE MEXICO S. DE R.L. DE C.V. T2100 TREADMILL; TREADMILL, POWERED

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CRITIKON DE MEXICO S. DE R.L. DE C.V. T2100 TREADMILL; TREADMILL, POWERED Back to Search Results
Model Number 2024315-001
Device Problem Unintended System Motion (1430)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Ge healthcare's investigation has been completed and it has been confirmed that this event occurred due to recall fmi (b)(4) was not performed on this treadmill, which was to replace the drive motor to correct the uncontrolled motion.Fmi (b)(4) was not applied because of the inability to locate the device.Ge healthcare made three mandatory attempts at the time fmi (b)(4) was executed to locate this device but was unsuccessful.To correct this issue, a new drive motor was installed, and the device was returned to the customer for clinical use.No further actions are needed.
 
Event Description
This report summarizes 1 malfunction event.The customer alleges that the tm 2100 powered treadmill model number 2024315-001 sped up and then went in reverse.There was no patient on the treadmill at the time of the issue and therefore no injury occurred.
 
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Brand Name
T2100 TREADMILL
Type of Device
TREADMILL, POWERED
Manufacturer (Section D)
CRITIKON DE MEXICO S. DE R.L. DE C.V.
calle valle del cedro 1551
juarez 32575
MX  32575
Manufacturer Contact
youssef halas
8200 west tower avenue
milwaukee, WI 
MDR Report Key8555978
MDR Text Key146651974
Report Number3008729547-2019-00003
Device Sequence Number1
Product Code IOL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Type of Report Initial
Report Date 04/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number2024315-001
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/01/2019
Initial Date FDA Received04/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/1970
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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