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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MORTARA INSTRUMENT, INC MORTARA ELECTROCARDIOGRAPH

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MORTARA INSTRUMENT, INC MORTARA ELECTROCARDIOGRAPH Back to Search Results
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Inappropriate Waveform (2536)
Patient Problem Cardiac Arrest (1762)
Event Date 06/29/2018
Event Type  Injury  
Manufacturer Narrative

The customer provided 2 pdf files of the ecg obtained on (b)(6) 2018 at 07:32:26. The first pdf is an ecg with an unconfirmed, device provided interpretation of atrial fibrillation and nonspecific t-wave abnormality. In the second pdf, the physician followed the expected workflow. He removed the interpretation statement provided by the device based on his over-read of the patient's waveform. The physician added his interpretation analysis to the ecg and then electronically signed the report. The physician's interpretation of the ecg did not include atrial fibrillation. He read the ecg as sinus rhythm with first degree av block with occasional superventricular premature complexes, nonspecific t-wave abnormality. Per the devices instructions for use, the interpretation statement provided by the device is for consideration only after review by a physician, to be used in conjunction with all other relevant patient data and is not a sole means for diagnosis and/or treatment. The customer was contacted multiple times; however, no additional information regarding this event could be obtained.

 
Event Description

The customer acquired an electrocardiogram (ecg) with the eli 380. The interpretation statement provided by the eli 380 device stated atrial fibrillation. Based on the interpretation statement, the patient was given a calcium channel blocker. The customer alleges that the patient experienced a cardiac arrest secondary to medication. Review of the ecg waveform showed that the patient was not in atrial fibrillation and therefore the patient may not have required the calcium channel blocker. Per the physician the patient did not have atrial fibrillation but did have sepsis and sinus tachycardia. It is unknown whether the patient had any risk factors for cardiac arrest in addition to the calcium channel blocker. This report was filed in our complaint handling system as complaint (b)(4).

 
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Brand NameMORTARA
Type of DeviceELECTROCARDIOGRAPH
Manufacturer (Section D)
MORTARA INSTRUMENT, INC
7865 north 86th street
milwaukee WI 53224 3431
Manufacturer Contact
mark elliott
7865 north 86th street
milwaukee, WI 53224-3431
MDR Report Key7893696
MDR Text Key120860608
Report Number2183461-2018-00003
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/21/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/20/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2018
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 09/20/2018 Patient Sequence Number: 1
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