ECG CABLES AND LEADSETS
Received Jan 17, 2026 · Event occurred Oct 7, 2025
Report 9610816-2026-100098 · MDR key 24105426
Device
Generic name
Cable, Transducer And Electrode, Patient, (including Connector)
Manufacturer
Philips Medizin Systeme Böblingen GmbhModel number
5 LEADSET, SNAP, AAMI, ICUCatalog number
989803144991
Product problems
- Incorrect Measurement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT ECG LEAD SET IS NOT PROVIDING THE CORRECT READINGS. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.
Additional Manufacturer Narrative
A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE TO THE CUSTOMER BIOMED WHO STATED THAT DURING A PREVENTIVE MAINTENANCE CHECK THE LEAD SET WAS PROVIDING INACCURATE READINGS. FURTHER INVESTIGATION FOUND THE LEAD SET WAS DAMAGED AND NEEDED TO BE REPLACED. REPLACEMENT PARTS WERE ORDERED AND SHIPPED TO THE CUSTOMER SITE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. REPORTING INSTITUTION PHONE # (B)(6). REPORTER PHONE # (B)(6).