MAUDE Adverse Event Report: MORTARA INSTRUMENT, INC MORTARA; ELECTROCARDIOGRAPH

Device Problems Incorrect, Inadequate or Imprecise Result or 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).

• Brand Name: MORTARA
• Type of Device: ELECTROCARDIOGRAPH
• 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 Key: 7893696
• MDR Text Key: 120860608
• Report Number: 2183461-2018-00003
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• 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
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/20/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 64 YR