MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	HEMOXSC100
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	05/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: dqe, qaq, mud, dxn, dsb, qms, fll.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, during use, an oximetry cable was not giving appropriate readings.Issue was resolved by using a new cable.There were no damages and no patient harm.Further information not available.
Additional Manufacturer Narrative
A product evaluation was completed on the returned oximetry cable.When the cable was connected to a hemosphere system, it caused an oximetry cable malfunction fault.There were no faults when a known working ox prism preamp pcba was installed.The fault returned when the original was reinstalled.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.A device history record review was completed and documented that device met all specifications upon distribution.Per product evaluation, the source of failure was due to the pre-amp interface board therefore the cause was traced to a component failure.Current risk mitigations include testing oximetry cables with keyed connectors that only plug in a given orientation.

• Brand Name: HEMOSPHERE
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92604
• Manufacturer (Section G): EDWARDS LIFESCIENCE; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 22080123
• Report Number: 2015691-2025-04091
• Device Sequence Number: 8397942
• Product Code: DQK
• UDI-Device Identifier: 00690103196986
• UDI-Public: (01)00690103196986(11)230916
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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
• Device Model Number: HEMOXSC100
• Device Lot Number: 18801627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2023
• 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