MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR FLOTRAC, VAMP; COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION

Model Number	MHD6AZ
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a flotrac device had inaccurate blood pressure values.Flotrac was attached to a hemosphere and non edwards bedside monitor, ge healthcare.Clinician noted that the flotrac displayed unexpected spikes in the blood pressure readings.Exchanging the device resolved the issue.No patient injuries.Used device was discarded.
Additional Manufacturer Narrative
The device was discarded at hospital.Without return of the unit, it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.Further evaluation regarding related quality issues is under investigation.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 a part of the monthly review.
Additional Manufacturer Narrative
A device history record review was completed and documented that device met all specifications upon distribution.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 a part of the monthly review.
Additional Manufacturer Narrative
Udi related data quality updates only.The following are additional product codes for this device: drs : transducer, blood-pressure, extravascular.Dqe : catheter, oximeter, fiberoptic.The following is corrected data, as the original identification information sent did not match the data submitted to the global unique device identification database (gudid): d1 brand name: flotrac, vamp.D2a common device name: computer, diagnostic, pre-programmed, single-function.D2b device product code: dxg.

• Brand Name: FLOTRAC, VAMP
• Common Device Name: COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
• 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: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 17970672
• Report Number: 2015691-2023-16936
• Device Sequence Number: 7119706
• Product Code: DXG
• UDI-Device Identifier: 00690103194722
• UDI-Public: (01)00690103194722(17)250310(11)230311(10)64922040
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K043065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/10/2025
• Device Model Number: MHD6AZ
• Device Lot Number: 64922040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/28/2023; 07/18/2024
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 12/01/2023; 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2023
• 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 Sex: Unknown