MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. GE T2100 TREADMILL; TREADMILL, POWERED

Model Number T2100

Device Problems Improper or Incorrect Procedure or Method (2017); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2019

Event Type  malfunction  

Event Description

Patient was having exercise stress test.After 12:02 minutes the stop button was accidentally deployed on patient's left grab bar as rn was taking bp while patient was walking on tm (tread mill).The left grab bar has an automatic stop button in addition to a pull cord from underneath the bar.This caused treadmill to suddenly stop which did not cause patient harm.This caused the treatment portion of the test to be reordered and restarted.This design appears to be a poor design when staff approach patient from the patient's left side.Clinical engineering staff attached a plastic button cover with velcro to prevent the automatic stop button from accidentally being pushed while nurses are attending to the patient.Manufacturer response for treadmill, ge t2100 model treatmill (per site reporter).Ge medical customer service notified of equipment event.Complaint ref #(b)(4).I was contacted by ge tech support at (b)(6), extension (b)(6).No intervention planned.I asked that our concerns be shared with ge development team for new treadmill models in an effort to increase patient safety.

• Brand Name: GE T2100 TREADMILL
• Type of Device: TREADMILL, POWERED
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.; 8200 west tower ave; milwaukee WI 53223
• MDR Report Key: 9488518
• MDR Text Key: 171816066
• Report Number: 9488518
• Device Sequence Number: 1
• Product Code: IOL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T2100
• Device Catalogue Number: T2100-ST2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/03/2019
• Device Age: 1 YR
• Date Report to Manufacturer: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18250 DA
• Patient Weight: 90