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

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	02/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Additional fda product code: dqe, qaq, mud, dxn, dsb, qms, fll.
Event or Problem Description
It was reported that during use, a hemosphere monitor displayed inaccurate pressure values.The monitor was on a sales rep and showed a systolic blood pressure that was 90-100mmhg above the expected values.There were no patient injuries.The device is available for evaluation.
Additional Manufacturer Narrative
Additional information of the event was received during follow up with clinical field representative.The clinical field representative had inaccurate values when testing the hem1 monitor with a new fingercuff while using the same pc2k cable and module that was used in the event.He then plugged the same fingercuff, pc2k cable, and module into other monitors and had accurate values.
Additional Manufacturer Narrative
A product evaluation was completed on the returned monitor.The reported event was unable to be confirmed.Monitor displayed normal blood pressure readings and waveform while connected to a known working hemcsm10, hempc2k, hrs and simulator.There were no visible physical damage and no error messages observed.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.The reported issue could not be confirmed with product evaluation and no product nor process malfunction was identified.A device history record review was completed and documented that device met all specifications upon distribution.

• 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 21597610
• Report Number: 2015691-2025-01886
• Device Sequence Number: 9034696
• Product Code: DQK
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)180828
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2025

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 Expiration Date: 10/03/2023
• Device Model Number: HEM1
• Device Lot Number: 13811245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 03/20/2025; 06/06/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 04/04/2025; 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown