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U.S. Department of Health and Human Services

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

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MORTARA INSTRUMENT, INC. STRESS TEST ELECTROCARDIOGRAPH - X - SCRIBE II STRESS TESTING SYSTEM Back to Search Results
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.

 
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Brand NameSTRESS TEST
Type of DeviceELECTROCARDIOGRAPH - X - SCRIBE II STRESS TESTING SYSTEM
Manufacturer (Section D)
MORTARA INSTRUMENT, INC.
7865 north 86th st
milwaukee WI 53224
MDR Report Key7910525
MDR Text Key121861163
Report NumberMW5080136
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 09/24/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/25/2018
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 the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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