MAUDE Adverse Event Report: MORTARA INSTRUMENT, INC. STRESS TEST; ELECTROCARDIOGRAPH - X - SCRIBE II STRESS TESTING SYSTEM

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 09/23/2018

Event Type  malfunction  

Event Description

It was reported that a cardiovascular technician was performing a graded exercise test on the patient.When it was time to place the patient in a recovery status, (b)(6) stated that the stress cart froze up and exited the test.She unable to retrieve anymore information of capture remaining ecg¿s.

• Brand Name: STRESS TEST
• Type of Device: ELECTROCARDIOGRAPH - X - SCRIBE II STRESS TESTING SYSTEM
• Manufacturer (Section D): MORTARA INSTRUMENT, INC.; 7865 north 86th st; milwaukee WI 53224
• MDR Report Key: 7910525
• MDR Text Key: 121861163
• Report Number: MW5080136
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1