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

Catalog Number	MDSZOL200
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Pad would not "synchronize" with monitor.
Additional Manufacturer Narrative
It was reported that when using the device "the zoll monitor was unable to synchronize to the r wave and thus could not deliver a shock when the patient needed to be cardioverted.They attempted to adjust the pads and even restarted the zoll machine, but to no avail".It was reported that the device was switched out for "a lingering zoll branded pad" and "they we able to cardiovert successfully".It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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.

• Common Device Name: PAD, DEFIB, ADULT, RADIOTRANS, ZOLL
• 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: 22905187
• Report Number: 1417592-2025-00419
• Device Sequence Number: 7911426
• Product Code: MKJ
• UDI-Device Identifier: 10888277635098
• UDI-Public: 10888277635098
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 08/27/2025

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: MDSZOL200
• Device Lot Number: Y041825-02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 08/27/2025
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown