MAUDE Adverse Event Report: CARDIAC SCIENCES Q-STRESS; STRESS TEST TREADMILL

Model Number Q-STRESS

Device Problem Failure to Shut Off (2939)

Patient Problems Fall (1848); Injury (2348)

Event Date 07/14/2014

Event Type  malfunction  

Event Description

The q-stress cardiovascular stress test treadmill would not turn off when the stop button was pushed nor when the program was closed out on the computer causing a patient fall and an employee injury.

• Brand Name: Q-STRESS
• Type of Device: STRESS TEST TREADMILL
• Manufacturer (Section D): CARDIAC SCIENCES; n7 w22025 johnson drive; wavkesha WI 53186
• MDR Report Key: 3949389
• MDR Text Key: 4603358
• Report Number: MW5037301
• Device Sequence Number: 1
• Product Code: IOL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Q-STRESS
• Other Device ID Number: 24018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1