MAUDE Adverse Event Report: GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES MEDLINE; DEFIBRILLATOR PAD

Model Number MDSPHY100LO

Device Problem Arcing (2583)

Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Date 07/25/2023

Event Type  Injury  

Event Description

Critically ill patient harmed when defibrillator pad made a sparking noise and patients beard caught fire.Patient sustained first and second degree burns to chest and face.Silvadene applied for treatment.

Manufacturer Narrative

A dhr review was completed and there were no noted nonconformances within the dhr.Product testing met all specifications and there were no issues identified with the raw materials used.The sample was returned for evaluation.Apex pad did not show any signs of heat damage however the sternum pad showed char marks.It was noted that there was excessive hair adhered to the sternum pad.Further investigation did confirm that the patient was not shaved prior to use of the pads.This could lead to poor adherence to the skin and cause an air gap to be present.

• Brand Name: MEDLINE
• Type of Device: DEFIBRILLATOR PAD
• Manufacturer (Section D): GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES; 400 exchange street; buffalo NY 14204
• Manufacturer Contact: juliana scotto di carlo ; 400 exchange street; buffalo, NY 14204 ; 7168496419
• MDR Report Key: 17816785
• MDR Text Key: 324241259
• Report Number: 1317188-2023-00011
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/26/2023

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 Operator: Health Professional
• Device Model Number: MDSPHY100LO
• Device Catalogue Number: 6600235H
• Device Lot Number: Y101322-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other