MAUDE Adverse Event Report: INFOBIONIC INC. MOME KARDIA; AMBULATORY ECG MONITORING AND DETECTION SYSTEM

Model Number 01854

Device Problems Thermal Decomposition of Device (1071); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 07/13/2020

Event Type  Injury  

Manufacturer Narrative

Based on observations, evidence, assessment and analysis, it is concluded that the battery pack was not in the monitor and not powering the monitor at the time of the adverse event.It is also concluded that the battery pack was dislodged from the monitor and that an external action, such as rolling over of the body over device system or some other physical action, likely during the eeg procedure, most likely contributed to the dislodging of the battery pack from the monitor.The burning/melting damage of the battery pack is indicative of thermal runaway due to internal battery cell short.The battery pack investigation and analysis indicated pre-existing mechanical damage to the battery pack casing such as chipped corner and broken tabs, not due to the burning/melting.The chipped corner location is in very close proximity of the battery pouch rupture location.The chipped corner is indicative of damage induced due to some strong mechanical impact, most likely dropping of the battery pack possibly multiple times during the life of the battery pack.It is also likely that since the battery pack was dislodged from the monitor, it was subjected to some external impact such as the patient rolling over the battery pack causing further physical damage to the battery pack casing.This cumulative physical damage highly likely penetrated the battery cell pouch surface and caused an internal short which resulted in thermal runway which in turn resulted in burning and melting of the battery pack.(b)(4).

Event Description

An adverse event involving li-ion battery pack which is component of infobionic mome kardia device was reported by medical practice staff.The event was reported to be happened at the practice location while patient was fitted with mome kardia device for ambulatory ecg monitoring and going through another separate procedure of eeg.Following was emailed by practice contact person, "the patient was fitted with the device on the left side of the abdomen.After a while she was place on lying face up on a bed where she was going to have an eeg, suddenly there was smoke coming out of the patient's shirt and the eeg tech noted sparks and patient scream because of the pain up off the bed and pull the device off.When she pulled her shirt up she had an area of skin loss surrounded with black marks.There was an intense smell in the office of burn plastic and burned skin.She was then seen by one of our doctors." during the initial notification call the practice contact person stated that one of the devices exploded on the patient when the device was on the patient and caused severe burns to the patient.The battery was reported to be melted and caused 2nd degree burns to the patient on torso.The device serial number was reported as (b)(4).It was also reported that the patient wearing (b)(4) was placed on service on the same day prior to having an eeg performed.During the eeg procedure, the battery in the mome device melted and caused 2nd degree burns based on the doctor's description.He claimed that the device was dry at the time but in the eeg environment.The mome kardia device including monitor, battery pack and other components of the device were returned back.The burning and melting of the li-ion battery pack was confirmed.The battery pack was found to be charred and melted.The battery pack cover which contains the battery pack label was melted and deformed along with the label.The battery box was mechanically damaged with several cracks, sharp indentations and substantial deformation.

• Brand Name: MOME KARDIA
• Type of Device: AMBULATORY ECG MONITORING AND DETECTION SYSTEM
• Manufacturer (Section D): INFOBIONIC INC.; 200 5th ave, 4030; waltham, ma
• Manufacturer (Section G): INFOBIONIC INC; 200 5th ave, 4030; waltham, ma
• Manufacturer Contact: dave maccutcheon ; 200 5th ave, 4030; waltham, ma ; 7556602
• MDR Report Key: 10393631
• MDR Text Key: 202497742
• Report Number: 3010112812-2020-00001
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: B690MK10
• UDI-Public: +B690MK10
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 01854
• Device Lot Number: 052018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Weight: 90