MAUDE Adverse Event Report: CARDIOLOGS INC CARDIOLOGS HOLTER PLATFORM

Model Number 2.3.13

Device Problems Failure to Capture (1081); Capturing Problem (2891)

Patient Problem Ventricular Fibrillation (2130)

Event Date 03/17/2023

Event Type  Death  

Event Description

Customer reported that a patient died while under the use of an ecg recording device.The ecg information was transmitted to the cardiologs platform which is utilized to analyze the ecg recording from that patient.Customer is claiming  the cardiologs platform missed a pause/vf from the patient's recording.

Manufacturer Narrative

Customer reported that a patient died while under the use of an ecg recording device.The ecg information was transmitted to the cardiologs platform which is utilized to analyze the ecg recording from that patient.Customer is claiming  the cardiologs platform missed a pause/vf from the patient's recording.However, indications for use of the cardiologs platform do not claim an ability to detect vf.Cardiologs has requested additional details behind the event to understand the circumstances of the use, the patient, and have yet to hear back from the customer.A follow up report will be updated upon further investigation of the incident.

Manufacturer Narrative

The customer mentioned two recordings ((b)(4)) where cardiologs misses vf and asystole identification in the ecg analysis report.Further research was performed to look into historical preventice recordings to understand how the device has performed in regard to pauses to make them more comfortable that these cases are "normal/expected" occasional misses and not a sign of a deeper problem.A 12 month look back at all preventice recordings (encompassing 400k) to further analyze the efficacy of our pause detection.Our detection is performing at or above the levels we would always expect and believe these concerns to be both valid, but within reason.

• Brand Name: CARDIOLOGS HOLTER PLATFORM
• Type of Device: CARDIOLOGS HOLTER PLATFORM
• Manufacturer (Section D): CARDIOLOGS INC; 136 rue saint denis; paris, paris 75002 ; FR 75002
• Manufacturer (Section G): CARDIOLOGS INC; 136 rue saint denis; paris, paris 75002 ; FR 75002
• Manufacturer Contact: natasha barnes ; 136 rue saint denis; paris, paris 75002 ; FR 75002
• MDR Report Key: 16752764
• MDR Text Key: 313425271
• Report Number: 1000341190-2023-00001
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 04/17/2023

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
• Device Model Number: 2.3.13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2023
• Supplement Dates Manufacturer Received: 12/11/2023
• Supplement Dates FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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): Death