CARDIOLOGS PLATFORM V2.4.7
Report
- Report Number
- 1000341190-2025-00005
- Event Type
- Injury
- Date Received
- October 3, 2025
- Date of Event
- February 8, 2025
- Report Date
- December 10, 2025
- Manufacturer
- PHILIPS FRANCE
- Product Code
- DPS
- PMA / PMN Number
- K212112
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- 505
Narratives
THE CLIENT REPORTED AN EVENT ASSOCIATED WITH A POTENTIAL MISSED 21 SECOND PAUSE AND DELAYED PLACEMENT OF A PACEMAKER AS A RESULT. P TRIGGERED FOR PAUSE/ASYSTOLE. WAS NOT SENT TO THE EVENT QUEUE SO "ANALYZED BY CARDIOLOGS." EVENT WAS PROCESSED DURING HIGH/LOW HR VALIDATION. BECAUSE THE ONLY STRIPS FOR THE DAY WERE THE HIGH/LOW CONFIRMED HR STRIPS THE DAILY REPORT WAS AUTOMATICALLY APPROVED BY THE SYSTEM SO THE EVENTS ON THE REPORT (ATTACHED) WERE NEVER PRESENTED TO A TECHNICIAN FOR REVIEW OTHER THAN DURING THE HIGH/LOW HR VALIDATION, WHICH IS ONLY TO VALIDATE HIGH/LOW HR AND NOT INTERPRET RHYTHMS. THIS WAS BROUGHT TO OUR ATTENTION BY THE PROVIDER, AND THEY WANTED TO KNOW IF THIS WAS ARTIFACT OR REAL. IT APPEARS TO BE REAL. THIS IS A PRODUCT ISSUE. THE SYSTEM AUTO APPROVES MCT DAILY REPORT IF THE ONLY STRIPS FOR THE DAY ARE HIGH/LOW. THIS HAS BEEN AN ONGOING PROBLEM. THE SYSTEM PROBABLY SHOULDN'T BE AUTO APPROVING THESE REPORTS.
THE CLIENT REPORTED AN EVENT ASSOCIATED WITH A POTENTIAL MISSED 21 SECOND PAUSE AND DELAYED PLACEMENT OF A PACEMAKER AS A RESULT. P TRIGGERED FOR PAUSE/ASYSTOLE. WAS NOT SENT TO THE EVENT QUEUE SO "ANALYZED BY CARDIOLOGS." EVENT WAS PROCESSED DURING HIGH/LOW HR VALIDATION. BECAUSE THE ONLY STRIPS FOR THE DAY WERE THE HIGH/LOW CONFIRMED HR STRIPS THE DAILY REPORT WAS AUTOMATICALLY APPROVED BY THE SYSTEM SO THE EVENTS ON THE REPORT (ATTACHED) WERE NEVER PRESENTED TO A TECHNICIAN FOR REVIEW OTHER THAN DURING THE HIGH/LOW HR VALIDATION, WHICH IS ONLY TO VALIDATE HIGH/LOW HR AND NOT INTERPRET RHYTHMS. THIS WAS BROUGHT TO OUR ATTENTION BY THE PROVIDER, AND THEY WANTED TO KNOW IF THIS WAS ARTIFACT OR REAL. IT APPEARS TO BE REAL. THIS IS A PRODUCT ISSUE. THE SYSTEM AUTO APPROVES MCT DAILY REPORT IF THE ONLY STRIPS FOR THE DAY ARE HIGH/LOW. THIS HAS BEEN AN ONGOING PROBLEM. THE SYSTEM PROBABLY SHOULDN'T BE AUTO APPROVING THESE REPORTS.
IT WAS REPORTED THAT ON (B)(6) 2025, THE CLIENT REPORTED AN EVENT ASSOCIATED WITH A POTENTIAL 21 SECOND MISSED PAUSE LED TO A DELAY OF PLACEMENT OF A PACEMAKER. THE CLINIC STATED THAT THE PATIENT REQUIRED A PACEMAKER AND THE PACEMAKER PLACEMENT WAS DELAYED DUE TO THE FAILURE TO NOTIFY PER PHYSICIANS DEFINED CRITERIA. IT WAS REPORTED THAT THE CLINIC FOUND THE PAUSE THEMSELVES IN THE A CUT STRIP IN A DAILY REPORT. IT WAS NOTED THAT THE PAUSE WAS NEVER SENT FOR A TECHNICIAN TO REVIEW ON (B)(6) 2025. ON (B)(6) 2025, THE EVENT WAS LABELED AS "CONFIRMED DAILY LOW HEARTRATE (HR) STRIP." THE DAILY REPORT WAS GENERATED ON (B)(6) 2025 AND THE CLINIC CALLED THAT DAY TO INQUIRE ABOUT A "FLAT-LINE" EVENT NOTED ON THE DAILY REPORT. THE CLINICAL LIAISON TEAM INVESTIGATED AND DETERMINED THAT IT WAS A TRUE PAUSE EVENT. ON (B)(6) 2025, IT WAS REPORTED THAT THE CLINICAL LIAISON TEAM DETERMINED THAT THERE WAS A DELAY IN IDENTIFICATION OF THE PAUSE EVENT THAT LED TO A DELAY IN PACEMAKER PLACEMENT BY AT LEAST 2 DAYS. NO ADDITIONAL INFORMATION PROVIDED.
IT WAS REPORTED THAT ON (B)(6) 2025, THE CLIENT REPORTED AN EVENT ASSOCIATED WITH A POTENTIAL 21 SECOND MISSED PAUSE LED TO A DELAY OF PLACEMENT OF A PACEMAKER. THE CLINIC STATED THAT THE PATIENT REQUIRED A PACEMAKER AND THE PACEMAKER PLACEMENT WAS DELAYED DUE TO THE FAILURE TO NOTIFY PER PHYSICIANS DEFINED CRITERIA. IT WAS REPORTED THAT THE CLINIC FOUND THE PAUSE THEMSELVES IN THE A CUT STRIP IN A DAILY REPORT. IT WAS NOTED THAT THE PAUSE WAS NEVER SENT FOR A TECHNICIAN TO REVIEW ON (B)(6) 2025. ON (B)(6) 2025, THE EVENT WAS LABELED AS "CONFIRMED DAILY LOW HEARTRATE (HR) STRIP." THE DAILY REPORT WAS GENERATED ON (B)(6) 2025 AND THE CLINIC CALLED THAT DAY TO INQUIRE ABOUT A "FLAT-LINE" EVENT NOTED ON THE DAILY REPORT. THE CLINICAL LIAISON TEAM INVESTIGATED AND DETERMINED THAT IT WAS A TRUE PAUSE EVENT. ON (B)(6) 2025, IT WAS REPORTED THAT THE CLINICAL LIAISON TEAM DETERMINED THAT THERE WAS A DELAY IN IDENTIFICATION OF THE PAUSE EVENT THAT LED TO A DELAY IN PACEMAKER PLACEMENT BY AT LEAST 2 DAYS. NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2427347 | CARDIOLOGS PLATFORM V2.4.7 | ELECTROCARDIOGRAM-CARDIOLOGS PLATFORM | DPS | PHILIPS FRANCE | V2.4.7 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |