MAUDE Adverse Event Report: CRITIKON DE MEXICO S. DE R.L. DE C.V. TM-2100; POWERED TREADMILL

Model Number TM-2100

Device Problem Break (1069)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 08/27/2015

Event Type  Injury  

Manufacturer Narrative

Patient information currently unavailable.Incident date unknown.Ge healthcare's investigation is on-going.A follow-up report will be submitted when the investigation is complete.Device evaluation anticipated, but not yet begun.

Event Description

The customer reported that the patient stopped walking as the treadmill continued to move, the patient fell and broke their leg.No additional information has been able to be obtained regarding patient treatment.

Manufacturer Narrative

The treadmill tdu log file was reviewed and confirmed normal operation with no errors present.There was also no indication of an emergency stop being pressed on the reported incident date.Patient data or the printout of the patient test record was requested, but that request was denied.The root cause is use error.The investigation supports the hospital¿s conclusion that the patient stopped walking on a moving belt causing them to fall off the back of the treadmill and be injured.The patient did not step off the belt onto the non-moving foot rests on the side of the belt.No defects were found within the treadmill that would have contributed to this event.There is no evidence of unusual treadmill behavior that contributed to the patient fall.Additional information: (b)(6).The patient broke an arm, not a leg as first indicated.

Event Description

The customer reported that the patient stopped walking as the treadmill continued to move, the patient fell and broke their arm.No additional information has been able to be obtained regarding patient treatment.

• Brand Name: TM-2100
• Type of Device: POWERED TREADMILL
• Manufacturer (Section D): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle el cedro 1551; juarez 32575 ; MX 32575
• Manufacturer (Section G): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle el cedro 1551; juarez 32575 ; MX 32575
• Manufacturer Contact: deb lahr ; 540 w. northwest hwy.; barrington, IL 60010
• MDR Report Key: 5271259
• MDR Text Key: 32811853
• Report Number: 3008729547-2015-00018
• Device Sequence Number: 1
• Product Code: IOL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nuclear Medicine Technologist
• Type of Report: Initial,Followup
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TM-2100
• Device Lot Number: SBC12059041SA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other