MAUDE Adverse Event Report: EPIC TECHNOLOGIES, LLC SEEQ; DETECTOR AND ALARM, ARRHYTHMIA

Model Number P01575-010

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Burn(s) (1757); Erythema (1840); Skin Irritation (2076)

Event Date 04/10/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by the patient that when the last sensor was removed, there was skin irritation described as "redness and 1st degree burns around the outer circle and 2nd degree burns around the inner circle." it was also reported that the patient talked to his cardiologist and they "both knew it was second degree burns." the patient treated the skin with over the counter cortisone cream and the skin is much better now.It was further reported that while answering a seeq customer experience survey the patient reported ¿it fell a few days earlier when it stopped working, i think it was not functioning for a few days." the sensor was not replaced.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

The device was returned and analyzed.Analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Corrected information: sex, date of birth, no eval explain code.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SEEQ
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): EPIC TECHNOLOGIES, LLC; 4240 irwin-simpson road; mason OH 45040
• Manufacturer (Section G): EPIC TECHNOLOGIES, LLC; 4240 irwin-simpson road; mason OH 45040
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6626348
• MDR Text Key: 77170933
• Report Number: 3010824444-2017-00002
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133701
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: P01575-010
• Device Catalogue Number: P01575-010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR