MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ALARM,TAMP-RESISTANT,LED/DUAL PAD,EA

Catalog Number	MDT8520TL
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the alarms all shows as low battery alarm.".
Additional Manufacturer Narrative
The customer states "the alarms all shows as low battery alarm"; the bio engineer was unaware how the product was stored when not in use or how it was being used at the time, maintenance was not done, and there was no shipping damage.Sample and/or photo provided? not available; pcn history reviewed and no product changes were identified that could have contributed to the alleged product failure; quality control inspections records reviewed and the lot number passed inspection per the inspection reports.Investigation results: not confirmed; the updated cause code is unconfirmed defect, sample required to determine cause.Corrective/preventive action taken/ecn/pcn¿s? no; the division will monitor through quarterly trending, and there has been no change to the reportability decision associated with this complaint.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: ALARM,TAMP-RESISTANT,LED/DUAL PAD,EA
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azmat shah ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50734657
• Report Number: 1417592-2026-37059
• Device Sequence Number: 10639183
• Product Code: KMI
• UDI-Device Identifier: 10193489020113
• UDI-Public: 10193489020113
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/11/2026

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: MDT8520TL
• Device Lot Number: 75722020001
• 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: 09/04/2024
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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