TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
Received Jun 5, 2026
Report 2015691-2026-15820 · MDR key 25404662
Device
Generic name
Transducer, Pressure, Catheter Tip
Manufacturer
Edwards Lifesciences DrModel number
PX2X2Lot number
66643543
Product problems
- Incorrect Measurement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AS REPORTED, THIS PRESSURE MONITORING SET HAD ZEROING DIFFICULTIES. ONCE THE ZERO COULD BE COMPLETED, THE ARTERIAL PRESSURE VALUES PROVIDED WERE NOT CORRECT (MANUFACTURER REFERENCE (B)(4) / FDA MDR REFERENCE 2015691-2026-15819). THEN, THE DEVICE WAS REPLACED; HOWEVER, SAME ISSUE OCCURRED WITH THE SECOND UNIT (MANUFACTURER REFERENCE (B)(4)). FINALLY, ISSUE WAS SOLVED USING A THIRD DEVICE. NO ERROR MESSAGE NOR ABNORMAL WAVEFORM WERE OBSERVED. THERE WERE NO FURTHER DETAILS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.
Additional Manufacturer Narrative
THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS; HOWEVER, IT HAS NOT YET BEEN RECEIVED. UPON THE RETURN OF THE PRODUCT A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.