MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; PAD,DEFIB,ADULT,RADIOLUCENT,PHYSIO

Catalog Number	MDSPHY100H
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, there was no gel on the defibrillator pads causing inability to shock patient and delayed the resuscitation process.The issue occurred while resuscitating a patient.There was no injury but care was delayed.There was no further information.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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility, there was no gel on the defib pads causing inability to shock patient and delayed the resuscitation process.
Additional Manufacturer Narrative
Corrected h6, c and d.

• Brand Name: MEDLINE
• Common Device Name: PAD,DEFIB,ADULT,RADIOLUCENT,PHYSIO
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 24521196
• Report Number: 1417592-2026-00189
• Device Sequence Number: 13184537
• Product Code: MKJ
• UDI-Device Identifier: 10888277635005
• UDI-Public: 10888277635005
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P200007
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MDSPHY100H
• Device Lot Number: Y071525-04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 05/05/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown