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

Catalog Number	HCSM70J
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the fingertip pulse oximeter (hcsm70j) was "not working even after changing the batteries." the item was defective.No injury, medical intervention, serious injury, or follow-up care has been reported.
Event or Problem Description
It was reported that the fingertip pulse oximeter (hcsm70j) was "not working even after changing the batteries.".

• Brand Name: MEDLINE
• Common Device Name: OXIMETER, PULSE, FINGERTIP, LED, W/ CASE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: sara young ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24927494
• Report Number: 1417592-2026-00444
• Device Sequence Number: 5168312
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2026

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown