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

Device Problems Device Operates Differently Than Expected (2913); Unintended Movement (3026)

Patient Problems Fall (1848); No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2017

Event Type  malfunction  

Manufacturer Narrative

The initial reporter is located outside the u.S.And therefore this information is not provided due to country privacy laws.Ge investigation is ongoing at this time.A follow-up will submitted when the investigation is complete.Device evaluation anticipated, but not yet begun.

Event Description

The customer alleges the treadmill 2100 went backwards and fast during patient use.There was no serious injury reported.

Manufacturer Narrative

The treadmill was returned to ge healthcare engineering for evaluation.It was concluded that the fmi30074 to replace the microflex drive was appropriately implemented.However, the customer subsequently replaced the microflex drive with a field replaceable unit (fru) which had not had the fmi applied resulting in an undoing of the fmi.Ge healthcare is sending out letters to impacted customers informing them of this potential defect if they maintained their own spare part inventory.Ge healthcare will also replace customer owned stock of the microflex drive including those that were already installed.

• Brand Name: TREADMILL SERIES 2100
• Type of Device: POWERED TREADMILL
• Manufacturer (Section D): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle del cedro 1551; juarez ; MX
• Manufacturer Contact: youssef halas ; 8200 w tower ave.; milwaukee, WI
• MDR Report Key: 6729914
• MDR Text Key: 80754603
• Report Number: 3008729547-2017-00009
• Device Sequence Number: 1
• Product Code: IOL
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: UDI NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2018
• 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
• Removal/Correction Number: 3005860720-04/10/18-002-
• Patient Sequence Number: 1
• Patient Age: 47 YR