MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; OXIMETER, PULSE, FINGERTIP, LED, W/ CASE

Catalog Number	HCSM70J
Medical Device Problem Codes	Unable to Obtain Readings (1516); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported both oximeters are defective and not functioning.A sample was received for investigation; 2 ea were reported but only 1 ea was received, and the sample was visually/physically evaluated with no damage or defects observed.During functional evaluation using a spo2 reader, the sample would give brief readings at low oxygen saturation levels, but quickly turn off and not hold the reading; the sample was evaluated again and would turn on only momentarily, then turn off.Medline could confirm the reported issue for the received sample; no sample or photo was received for the other reported device, no root cause was identified, no trends were identified, and the quality team will monitor this issue for trending purposes.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.
Event or Problem Description
It was reported that both oximeters are defective.They are not functioning.

• Brand Name: MEDLINE
• Common Device Name: OXIMETER, PULSE, FINGERTIP, LED, W/ CASE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: vamshi thupakula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50884051
• Report Number: 1417592-2026-49937
• Device Sequence Number: 9939344
• Product Code: OCH
• UDI-Device Identifier: 00197344065564
• UDI-Public: 00197344065564
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/23/2026

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: HCSM70J
• Device Lot Number: 202507017
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/25/2025
• 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: 11/07/2025
• Initial Report FDA Received Date: 09/24/2026
• 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