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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVIVO CORPORATION INVIVO QUADTRODE MRI ECG ELECTRODES

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INVIVO CORPORATION INVIVO QUADTRODE MRI ECG ELECTRODES Back to Search Results
Model Number 989803179031
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Skin Irritation (2076); Burn, Thermal (2530)
Event Type  Malfunction  
Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation.

 
Event Description

The user reported that a patient experienced a burn or allergic reaction after an mri. It was reported that the patient had a soft tissue neck, cervical and thoracic spine scan for a total of approximately 60 minutes scanning time (15:38- 16:21 on (b)(6) 2016). It was reported that there was some delay prior to scan while blood gasses were monitored on the patient. The patient then reportedly left the mr to have a chest x-ray before returning to intensive therapy unit. The quadtrode pad was reportedly removed in intensive therapy unit between 5-5:30 pm and the charge nurse who removed the quadtrode pad did not notice any marks on the patient. There was a report by the nursing staff of marks at 5:30 am on (b)(6) 2016. It was also reported that the patient has a sensitive skin type and, in the user's opinion, this may be an allergic reaction but that is not yet confirmed. We are awaiting further information on the treatment of this reaction, if any. On 23-nov-2016, it was reported that the marks on the patient have significantly faded. The user reports that the box of quadtrode pads has been removed from circulation, but that it had already been opened and some had been used already without incident prior to being used on this patient.

 
Manufacturer Narrative

It was reported that the patient experienced an allergic reaction to the quadtrode electrode. The user was provided with information about the composition of the electrodes so that the patient can avoid those components in the future.

 
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Brand NameINVIVO QUADTRODE MRI ECG ELECTRODES
Type of DeviceELECTRODES
Manufacturer (Section D)
INVIVO CORPORATION
12151 research parkway
suite 200
orlando FL 32826
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
denyse murphy
12151 research parkway
suite 200
orlando, FL 32826
MDR Report Key6134467
MDR Text Key61443911
Report Number1051786-2016-00017
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK955045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/09/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/30/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/07/2018
Device MODEL Number989803179031
Device LOT Number60307-0442
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/09/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/02/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

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