MORTARA TMX58110

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-14 for MORTARA TMX58110 manufactured by Mortara Instruments, Inc..

Event Text Entries

[73221707] New mortara treadmills stop spontaneously posing a hazard to cardiopulmonary rehab patients. Mortara rep notified and staff came to investigate and treadmills put back in service. Problem persists despite mortara looking into the matter. We are concerned about the potential hazard of our brand new treadmills stopping spontaneously.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5069143
• MDR Report Key: 6499859
• Date Received: 2017-04-14
• Date of Report: 2017-04-14
• Date of Event: 2017-04-12
• Date Added to Maude: 2017-04-18
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: MORTARA
• Generic Name: TREADMILL
• Product Code: IOL
• Date Received: 2017-04-14
• Model Number: TMX58110
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MORTARA INSTRUMENTS, INC.
• Manufacturer Address: MILWAUKEE WI 53224 US 53224

Device Sequence Number: 2

• Brand Name: MORTARA
• Generic Name: TREADMILL
• Product Code: IOL
• Date Received: 2017-04-14
• Model Number: TMX58110
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MORTARA INSTRUMENTS, INC.
• Manufacturer Address: MILWAUKEE WI 53224 US 53224

Device Sequence Number: 3

• Brand Name: MORTARA
• Generic Name: TREADMILL
• Product Code: IOL
• Date Received: 2017-04-14
• Model Number: TMX58110
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: MORTARA INSTRUMENTS, INC.
• Manufacturer Address: MILWAUKEE WI 53224 US 53224

Device Sequence Number: 4

• Brand Name: MORTARA
• Generic Name: TREADMILL
• Product Code: IOL
• Date Received: 2017-04-14
• Model Number: TMX58110
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: MORTARA INSTRUMENTS, INC.
• Manufacturer Address: MILWAUKEE WI 53224 US 53224

Device Sequence Number: 5

• Brand Name: MORTARA
• Generic Name: TREADMILL
• Product Code: IOL
• Date Received: 2017-04-14
• Model Number: TMX58110
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: MORTARA INSTRUMENTS, INC.
• Manufacturer Address: MILWAUKEE WI 53224 US 53224

Device Sequence Number: 6

• Brand Name: MORTARA
• Generic Name: TREADMILL
• Product Code: IOL
• Date Received: 2017-04-14
• Model Number: TMX58110
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 6
• Device Event Key: 0
• Manufacturer: MORTARA INSTRUMENTS, INC.
• Manufacturer Address: MILWAUKEE WI 53224 US 53224

Device Sequence Number: 7

• Brand Name: MORTARA
• Generic Name: TREADMILL
• Product Code: IOL
• Date Received: 2017-04-14
• Model Number: TMX58110
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 7
• Device Event Key: 0
• Manufacturer: MORTARA INSTRUMENTS, INC.
• Manufacturer Address: MILWAUKEE WI 53224 US 53224

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-04-14