MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR FLOTRAC SENSOR; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number	MHD8
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation since it was discarded at hospital.Without return of the product, it is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.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.
Event or Problem Description
As reported, during use with patient, the blood pressure value obtained with this flotrac sensor was too high and inaccurate.The expected value according to patient status was around 100 mmhg; however, the value provided by the device was unable to be obtained.The patient was not treated according to the inaccurate value.There was no allegation of patient injury.The device was not available for evaluation, since it was discarded.
Additional Manufacturer Narrative
Updated section h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions).The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.During the manufacturing process there are controls to avoid potential causes related to the reported malfunction.

• Brand Name: FLOTRAC SENSOR
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 22138683
• Report Number: 2015691-2025-04397
• Device Sequence Number: 12816032
• Product Code: DRS
• UDI-Device Identifier: 00690103194609
• UDI-Public: (01)00690103194609(17)260402(11)240402(10)65706842
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K242909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/02/2026
• Device Model Number: MHD8
• Device Lot Number: 65706842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 62 KG