MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MONITOR, BP, SPO2

Catalog Number	MDSVSMN1
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	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the spo2 is not working.
Additional Manufacturer Narrative
The customer stated they started using this and the spo2 is not working.Investigation details noted ¿servicing request,¿ and cause & defect details listed ¿sp02 readings off¿ with cause text ¿unconfirmed defect.¿ the reported problem was unconfirmed, and no root cause was identified.The reported complaint event was reviewed and did not involve a death or serious injury, and the information reviewed does not indicate that a death or serious injury would be likely to occur if the product problem/issue were to recur.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.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: MONITOR, BP, SPO2
• Manufacturer (Section D): Medline Industries, LP; IL
• Manufacturer Contact: kumar vigrahala ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50881973
• Report Number: 1417592-2026-49639
• Device Sequence Number: 9799542
• Product Code: DQA
• UDI-Device Identifier: 10193489012903
• UDI-Public: 10193489012903
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K180380
• 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): 09/23/2026

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: MDSVSMN1
• Device Lot Number: M25B18580062
• Was Device Available for Evaluation?: Yes
• 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: 03/18/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown