T2100 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-26 for T2100 * manufactured by Ge Healthcare.

Event Text Entries

[21837228] The treadmill will randomly stop during a bruce cycle. No patients have been harmed, but there is the potential for patient harm when the treadmill stops suddenly and without prior warning while the patient is using it. This facility has four of these devices; two of the devices have had this problem and the other two have the potential to have this problem. There is no warning that signals the staff or the patient that the problem will occur or is about to occur. We have been trying to contact the manufacturer x2 months regarding this issue. When calling, we are directed to an automated message on a special phone line that the manufacturer has set up for this specific problem. There have been no manufacturer return calls, no correspondence, and no service technicians on site for this issue. This facility began having problems with this device prior to the manufacturer issuing an action letter. Although calls and requests for service support were sent to the manufacturer prior to the action notice, this facility still has not received return communication from the manufacturer on this issue. ======================manufacturer response for stress machine, t2100 (per site reporter). ======================ge healthcare has issued a product alert for our stress machines. We cannot at this moment get a hold of ge to come in and recertify the treadmills.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4826878
• MDR Report Key: 4826878
• Date Received: 2015-05-26
• Date of Report: 2015-05-26
• Date of Event: 2015-04-06
• Report Date: 2015-05-26
• Date Reported to FDA: 2015-05-26
• Date Reported to Mfgr: 2015-06-09
• Date Added to Maude: 2015-06-09
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: T2100
• Generic Name: TREADMILL, POWERED
• Product Code: IOL
• Date Received: 2015-05-26
• Model Number: T2100
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: NURSE
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GE HEALTHCARE
• Manufacturer Address: 9900 W. INNOVATION DR., RP 213 WAUWATOSA , WI 53226 WI 53226 US 53226

Device Sequence Number: 2

• Brand Name: T2100
• Generic Name: TREADMILL, POWERED
• Product Code: IOL
• Date Received: 2015-05-26
• Model Number: T2100
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: GE HEALTHCARE
• Manufacturer Address: 9900 W. INNOVATION DR., RP 213 WAUWATOSA WI 53226 US 53226

Device Sequence Number: 3

• Brand Name: T2100
• Generic Name: TREADMILL, POWERED
• Product Code: IOL
• Date Received: 2015-05-26
• Model Number: T2100
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: GE HEALTHCARE
• Manufacturer Address: 9900 W. INNOVATION DR., RP 213 WAUWATOSA WI 53226 US 53226

Device Sequence Number: 4

• Brand Name: T2100
• Generic Name: TREADMILL, POWERED
• Product Code: IOL
• Date Received: 2015-05-26
• Model Number: T2100
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: GE HEALTHCARE
• Manufacturer Address: 9900 W. INNOVATION DR., RP 213 WAUWATOSA WI 53226 US 53226

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-05-26