MAUDE Adverse Event Report: EDWARDS LIFESCIENCE IRVINE HEMOSPHERE; CATHETER, OXIMETER, FIBEROPTIC

Model Number	HEM1
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	07/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product codes for the device include: dqk: computer, diagnostic, programmable.Qaq: adjunctive predictive cardiovascular indicator.Mud: oximeter, tissue saturation.Dxn: system, measurement, blood-pressure, non-invasive.Dsb: plethysmograph, impedance.Qms: adjunctive open loop fluid therapy recommender.Fll: thermometer, electronic, clinical.The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed.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.
Event or Problem Description
It was reported that the heart rate was not displayed on the hemosphere monitor, or it was displaying heart rate but showing unstable values such as 7 bpm or 14 bpm.The expected hr values were between 70 bpm and 90 bpm, similar to those shown by the patient monitor.There was no abnormality found in the waveform and it matched to the pressure value.The error message, alert sv heart rate signal missing, was displayed in the situation that hr values were not displayed.The issue was not considered to be affected by the patient condition.The analog cable was replaced, but no improvement was observed.No treatment was given to the patient based on the inaccurate values.No patient injury reported.
Additional Manufacturer Narrative
The device was not returned, however image and video were provided, and the complaint can be confirmed.Additionally, the device log was provided and evaluated, but the nonconformance cannot be confirmed as there was not enough information from the logs to investigate.No product was returned for evaluation.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.It is not known if some procedural factors may have contributed to the event.A device history record review was completed and documented that the 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 part of the monthly review.

• Brand Name: HEMOSPHERE
• Common Device Name: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCE IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCE IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 19940379
• Report Number: 2015691-2024-05981
• Device Sequence Number: 11981131
• Product Code: DQE
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)200711
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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: 07/20/2025
• Device Model Number: HEM1
• Device Lot Number: 13825606
• 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: 07/25/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown