MAUDE Adverse Event Report: Graphic Controls dba Nissha Medical Technologies Medline; Defibrillator Pad

Model Number	MDSPHY200
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
75 yom bib ems from snf obtunded/ unresponsive cardiac arrest pea.Intubated went into v-fib.Stryker lp35 connected to medline pads.Shock x1 at 360 joules.Appears spark from pad occurred, flame from pathway from defib pad to chest hair.Bvm on gurney on pathway.Burns to chest, neck, left arm, left flank with no specific burn treatment.Bag valve mask connected to oxygen near patient's left side.Patient skin was shaved prior to shock.
Additional Manufacturer Narrative
The dhr for lot y061126-04 was reviewed.It did not reveal any indication that the production process or raw materials contributed to the event.No nonconformances nor deviations were issued against this lot.The actual device was returned to nmt on (b)(6) 2026 and was visually inspected, but no functional testing was performed due to the damaged state of the device.Retain samples were visually inspected and tested.The samples performed as expected and no indications of sparking, popping, smoke, or general overheating were observed.Complaint history was reviewed which revealed this is the second complaint report of this part number.The first complaint received in (b)(6) 2025, (b)(4), reported a connection issue with a lifepak 20e defibrillator.The root cause of this complaint was determined to be user error and had no indication of death or injury with no association to this event.The information provided suggests that the environment of the emergency room may have contributed to the root cause of the event.Contributing factors of the event could possibly include presence of patient chest hair, oxygen rich enviornment, potential spark from pad inherent to these types of devices.Additionally, a stryker lifepak 35 defibrillator was used during the event, which nmt does not claim compatibility with for mdsphy200.At this time, it cannot be determined if defibrillator compatibility was a contributing factor to the event.On (b)(6) 2026, nmt was made aware by the end user that the product did not cause or contribute to the death.This mdr is being reported as a serious event, not a death, per fda instructions below: general instructions - for form fda 3500a medwatch (for mandatory reporting): "death: check if death was an outcome of the adverse event, or if the cause of the death is unknown.Include the date of death, if known.Do not check if: the patient died while using a product, but there was no suspected association between the death and the use of the product.".

• Brand Name: Medline
• Common Device Name: Defibrillator Pad
• Manufacturer (Section D): Graphic Controls dba Nissha Medical Technologies; 400 exchange street; buffalo NY 14204
• Manufacturer Contact: amy intini ; 400 exchange street; buffalo, NY 14204 ; +1(716)507-8135
• MDR Report Key: 50255256
• Report Number: 1317188-2026-00094
• Device Sequence Number: 10629716
• Product Code: MKJ
• UDI-Device Identifier: 10888277635029
• UDI-Public: 10888277635029
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: MDSPHY200
• Device Catalogue Number: 6600219H
• Device Lot Number: Y061126-04
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/24/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 127 LB
• Patient Race: White