MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; PAD, DEFIB, ADULT, RADIOTRAN, ZOLL, LO

Catalog Number	MDSZOL200LO
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that "these are not damaged they will not shock patient or we can not properly test to make sure they will shock with our defibrilator".No additional information has been provided despite attempts to obtain, 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
Pad will not shock patient.
Additional Manufacturer Narrative
Updated to include lot number and updated code (h6).

• Common Device Name: PAD, DEFIB, ADULT, RADIOTRAN, ZOLL, LO
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21753316
• Report Number: 1417592-2025-00158
• Device Sequence Number: 12811990
• Product Code: MLN
• UDI-Device Identifier: 10888277635104
• UDI-Public: 10888277635104
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 07/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: MDSZOL200LO
• Device Lot Number: Y071924-03, Y121824-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown