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

Catalog Number	HCSM70J
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per report, "customer called in stating the oximeter is no longer reading.Customer replaced the batteries and the oximeter is still not reading.Placed on finger, same as everyday, light came on, but no side light going up and down to acknowledge waiting for reading.Tried different fingers also.Nothing changed.Ironically had taken to my doctor appointment the day before to make sure my readings were correct.They were." 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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
Per report, "customer called in stating the oximeter is no longer reading.Customer replaced the batteries and the oximeter is still not reading.".

• Brand Name: MEDLINE OTC FINGERTIP PULSE OXIMETER
• Common Device Name: OXIMETER, PULSE, FINGERTIP, LED, W/ CASE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: sipara semu ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25095180
• Report Number: 1417592-2026-00889
• Device Sequence Number: 5031127
• Product Code: OCH
• UDI-Device Identifier: 00197344065564
• UDI-Public: 00197344065564
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 05/06/2026

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: 202409018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 56 KG