MAUDE Adverse Event Report: MEDLINE RENEWAL SERFAS ENERGY 90-S CRUISE; 279-401-200 SERFAS ENERGY 90-S CRUISE

Catalog Number	279401200RH
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that plugged device in and it would not connect or register.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
It was reported that, plugged device in and it would not connect or register.

• Brand Name: SERFAS ENERGY 90-S CRUISE
• Common Device Name: 279-401-200 SERFAS ENERGY 90-S CRUISE
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock avenue; redmond OR 94456 1876
• Manufacturer Contact: meghana maddilli ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25480796
• Report Number: 3032391-2026-00030
• Device Sequence Number: 13242156
• Product Code: NUJ
• UDI-Device Identifier: 10888277700659
• UDI-Public: 10888277700659
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K012669
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2026

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: 279401200RH
• Device Lot Number: 566102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male