MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; OXIMETER,PULSE,FINGER,BLUETOOTH WITH APP

Catalog Number	HCSM70T
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	03/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿device was giving inaccurate readings.Not working properly¿.
Additional Manufacturer Narrative
According to the customer, the reading gives different results than the current oximeter.A sample was received for investigation; the sample was visually inspected with no physical damage noticed, batteries were inserted, the sample turned on, and the sample was tested for accuracy using a fluke spot light functional tester with five different testing parameters.The sample passed 3 out of the 5 evaluation levels, slight variance at the lowest peripheral oxygen saturation reference levels were observed, and the complaint has been confirmed.The root cause is unknown, and the vendor investigation did not result in any findings that indicated the reported issue may have been caused by the vendor¿s manufacturing process.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: OXIMETER,PULSE,FINGER,BLUETOOTH WITH APP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shirisha mothe ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50895842
• Report Number: 1417592-2026-50671
• Device Sequence Number: 10761875
• Product Code: OCH
• UDI-Device Identifier: 00193489094261
• UDI-Public: 00193489094261
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• 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): 09/24/2026

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: HCSM70T
• Device Lot Number: 59522080001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/08/2025
• 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: 03/07/2025
• 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): 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