MAUDE Adverse Event Report: WELCH ALLYN, INC. QUINTON; TREADMILL, POWERED

Model Number MEDTRACK CR60

Device Problem Device Emits Odor (1425)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2019

Event Type  malfunction  

Event Description

A burning smell was noticed in the cardiac rehab area.The odor was traced to a treadmill.Staff called biomed to look at the treadmill.Upon inspection, a power capacitor had failed and causing the odor smell.

• Brand Name: QUINTON
• Type of Device: TREADMILL, POWERED
• Manufacturer (Section D): WELCH ALLYN, INC.; 7865 north 86th st.; milwaukee WI 53224
• MDR Report Key: 9284389
• MDR Text Key: 165234319
• Report Number: 9284389
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MEDTRACK CR60
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2019
• Device Age: 16 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1