MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE; HEMOSPHERE ADVANCED MONITOR

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	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were inaccurate values that displayed during patient use with a hemosphere monitor.The blood pressure reading on the hemosphere was displaying as 99/38 and the philips bedside unit was displaying as 109/42.The displayed numbers were different throughout the case.The procedure was an embolization case.There was no inappropriate patient treatment administered.There was no patient injury.
Additional Manufacturer Narrative
The unit has been requested to be returned for product evaluation; however, it has not arrived.Once it arrives and the evaluation has been completed the findings will be sent in a supplemental submission.The device history record review was completed and all manufacturing inspections passed with no non conformances.Additional product codes, dqk, qaq, mud, dxn, dsb, qms, fll.
Additional Manufacturer Narrative
The product was requested to be returned for evaluation, but did not arrive.A product evaluation could not be completed.Without its return, it is not possible to determine if there was damage or a defect that existed on the unit that could have contributed to the event.It is not known if any procedural factors may have contributed to the reported issue.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.As the complaint could not be confirmed, there is not sufficient evidence to determine a root cause.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.

• Brand Name: HEMOSPHERE
• Common Device Name: HEMOSPHERE ADVANCED MONITOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 21624723
• Report Number: 2015691-2025-01987
• Device Sequence Number: 6734369
• Product Code: DQE
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)211206
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2025

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 Model Number: HEM1
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown