CARDIOLOGS PLATFORM - V 2.4.8A

Report

Report Number: 1000341190-2025-00006
Event Type: Death
Date Received: October 7, 2025
Date of Event: July 2, 2025
Report Date: October 7, 2025
Manufacturer: PHILIPS FRANCE COMMERICAL
Product Code: DPS
PMA / PMN Number: K212112
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: 501

Narratives

Additional Manufacturer Narrative · 0

THIS IS A KNOWN CASE OF "PAUSE IN NOISE". IN ORDER TO REDUCE FALSE POSITIVES, WE REMOVE PAUSES DETECTED IN NOISY SIGNAL. THIS IS KNOWN AND WILL BE SIGNIFICANTLY IMPROVED IN OUR NEXT VERSION (ONGOING SUBMISSION). HOWEVER, THIS RECORDING IS ALSO NOT COMMON SINCE THERE ARE +4500 PAUSES DETECTED BY THE ALGO. THERE IS HOWEVER A PROBLEM WITH NOISE DETECTION IN THAT CASE, BECAUSE LARGE PORTIONS OF SIGNAL ARE DETECTED AS NOISE DESPITE FEW BEATS (VERY SLOW RHYTHM). YOU CAN SEE ON THE HRDP THAT THE PAUSES ARE DETECTED, AND MISSED ONLY WHEN THE SIGNAL IS CLASSIFIED AS NOISE.

Description of Event or Problem · 0

THE CUSTOMER BROUGHT A FILE WITH MISSED PAUSES ON 02 JULY 2025. THE CUSTOMER WAS REQUESTING TO ADD MORE INFORMATION AROUND A PERIOD OF TIME DURING A PATIENT'S HOLTER STUDY THAT WAS NOT IN THE ORIGINAL REPORT. THE PATIENT EXPIRED WHILE WEARING THE DEVICE PER FAMILY AND THEY WERE CURIOUS WHY THERE WAS NOT ANYTHING DOCUMENTED FOR THOSE TIMES. DURING THE INVESTIGATION OF THE TAPE SIGNIFICANT PAUSES WERE LOCATED. IT WAS NOTED THAT THE PAUSES WERE MISSED BY CARDIOLOGS, INCLUDING ONE THAT LASTED OVER 3 MINUTES. THE ONLY PAUSES THAT WERE PICKED UP IN THE FILE WERE FROM A PREVIOUS TIME PERIOD DURING THE STUDY, WHICH WERE NOTATED ON THE ORIGINAL REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2709958	CARDIOLOGS PLATFORM - V 2.4.8A	ELECTROCARDIOGRAM-CARDIOLOGS PLATFORM	DPS	PHILIPS FRANCE COMMERICAL	V 2.4.8A

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Death