MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NAMIC NAMIC; MTS,LEFT HEART,KIT,ATLANTICARE,REG MED

Catalog Number	60011433
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the transducer was unable to zero.Tried multiple thermodynamic cables and attempts.Due diligence has been completed and no additional details are available despite good faith efforts and the customer contact was unable or unwilling to provide further incident details to the manufacturer.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.
Event or Problem Description
Transducer unable to zero.Tried multiple thermodynamic cables and attempts.

• Brand Name: NAMIC
• Common Device Name: MTS,LEFT HEART,KIT,ATLANTICARE,REG MED
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NAMIC; 10 glens falls technical pk. d; technical park dr; glens falls NY 12801 3864
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25211347
• Report Number: 3015910259-2026-00124
• Device Sequence Number: 16060561
• Product Code: OEZ
• UDI-Device Identifier: 10193489040470
• UDI-Public: 10193489040470
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

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 Catalogue Number: 60011433
• Device Lot Number: 26ABH642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2026
• 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