MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PAD,DEFIB,ADULT,RADIOLUCENT,ZOLL,LO

Catalog Number	MDSZOL100LOH
Medical Device Problem Codes	Communication or Transmission Problem (2896); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was received, and the customer reported that medline radiolucent / radiotransparent defibrillator electrode pads "did not work with zoll machine"; no death or serious injury was reported.Investigation included review of recent complaint trends/scar activity for the last three trend reports; a sample was not received, and the vendor reported that through internal investigation, including dhr review and inspection records review, no abnormalities were found.The complaint was not confirmed, and without the sample or picture, it is difficult to truly identify the root cause of the issue; complaint history revealed trending for communication issues between the pad and zoll defibrillator, but the trend appears to be associated with setup or training issues at specific locations after changing from the oem to this device, rather than a device malfunction.Based on the review of the details provided for the complaint investigation, medline was unable to confirm the complaint issue or that the product failed to meet specifications.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 "these pads did not work with the customer's zoll machines.They wouldn¿t recognize them or receive any signal like the oem pads do.".

• Brand Name: MEDLINE
• Common Device Name: PAD,DEFIB,ADULT,RADIOLUCENT,ZOLL,LO
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kehkashan khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50793034
• Report Number: 1417592-2026-42731
• Device Sequence Number: 9607525
• Product Code: MKJ
• UDI-Device Identifier: 10888277635081
• UDI-Public: 10888277635081
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P200007
• 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): 09/15/2026

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: MDSZOL100LOH
• Device Lot Number: Y041625-01
• 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: 09/17/2025
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (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