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

Model Number 01854

Device Problem Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

The battery pack was received back from the patient with mechanical damage.The cover of battery pack, with lot code information, was missing.Investigation revealed extensive water damage to the battery pcm (protective circuit module).The water acted as an electrical current conductor allowing the current from the battery to bypass the protection circuitry and the energy stored in the battery was released momentarily.It was concluded that the battery pack was subjected to an impact, sufficient to break the ultrasonic weld and detach the battery cover.The damaged battery pack was subsequently placed on a surface with enough water present to seep across both sides of the pcm.This caused several components on the pcm pwa to short and overheat.

Event Description

The event was reported on standalone li-ion battery pack which is component of infobionic mome kardia device.The medical practice staff reported that the patient returned the device with battery pack with front (front cover of battery pack) off it.The inside of the battery pack was exposed.The area with the 6 gold bars was charred as well as charring on the silver colored plate.The patient's husband stated that he had just removed the battery from the monitor in order to place a fresh battery.He placed the used battery on the counter and he observed it "smoking".He stated that the battery had been used without incident up to this point.Single battery pack was involved with single patient.No patient injury or any other damage was reported as a result of this event.

• Brand Name: MOME KARDIA
• Type of Device: AMBULATORY ECG MONITORING AND DETECTION SYSTEM
• Manufacturer (Section D): INFOBIONIC INC.; 600 suffolk street; lowell MA 01854
• Manufacturer (Section G): INFOBIONIC INC.; 600 suffolk street; lowell MA 01854
• Manufacturer Contact: dave maccutcheon ; 600 suffolk street; lowell, MA 01854 ; 6177556602
• MDR Report Key: 8605199
• MDR Text Key: 144870789
• Report Number: 3010112812-2019-00001
• Device Sequence Number: 1
• Product Code: DSI
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 01854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2017
• 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: 79 YR