MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PKG ASSY HEM MONITOR; HEMOSPHERE INTRUMENT

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	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during use, the hemosphere 1 monitor experienced consistently low mean arterial pressure (map) v.Simultaneous non-invasive blood pressure (nibp).It was confirmed that there was no patient harm associated with the reported issue.
Additional Manufacturer Narrative
Additional product codes: dqe catheter, oximeter, fiberoptic 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.At this time, the suspect device has not returned for evaluation and investigation.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.The device history record review was completed and all manufacturing inspections passed with no non conformances.
Additional Manufacturer Narrative
There was no product evaluation as the device was discarded and not returned.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.
Additional Manufacturer Narrative
The suspect device was returned and evaluated by our engineering team.The customers reported issue could not be confirmed.The suspect device was evaluated, tested, and met all manufacturer specifications.Additionally, there was no evidence of product nonconformance or labeling/ifu inadequacies identified.

• Brand Name: PKG ASSY HEM MONITOR
• Common Device Name: HEMOSPHERE INTRUMENT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 22321655
• Report Number: 2015691-2025-05140
• Device Sequence Number: 21035764
• Product Code: DQK
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)230717
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2025

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?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 08/01/2025; 08/27/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 08/01/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown