MAUDE Adverse Event Report: Medline ReNewal Medline ReNewal; SENSOR, LNCS, ADULT

Catalog Number	MAXARH
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Unable to Obtain Readings (1516); Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction

• Brand Name: Medline ReNewal
• Common Device Name: SENSOR, LNCS, ADULT
• Manufacturer (Section D): Medline ReNewal; 1500 ne hemlock avenue; redmond OR 94456 -187
• Manufacturer Contact: brianna montgomery ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50902463
• Report Number: 3032391-2026-00197
• Device Sequence Number: 13438382
• Product Code: NLF
• UDI-Device Identifier: 10888277185326
• UDI-Public: 10888277185326
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K181738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: MAXARH
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/15/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown