MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION PRO*PADZ SOLID GEL RADIOLUCENT MULTI-FUNCTION ELECTRODES - 1 PAIR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 8900-4006

Device Problems Material Discolored (1170); Noise, Audible (3273)

Patient Problems Skin Discoloration (2074); Discomfort (2330)

Event Date 06/18/2021

Event Type  malfunction  

Event Description

Patient prepped for cardioversion; with delivery of energy all present heard a loud single pop sound.Patient in normal sinus rhythm (nsr) with stable vital signs (vs) throughout.Upon removal of anterior chest pad noted a darkened area on the inside of the pad and a light brown line on the patients' chest at the upper edge of where the pad had been.Zoll patches lot 1721d, ref (b)(4), exp 2022-04-24.Zoll surepower id #(b)(4).No discoloration on posterior/back skin or on pad.Medicated with tylenol for discomfort, refused ice.Silvadene ointment to site; to continue same at home.Biomed priority ticket placed, device removed from service.

• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 12273620
• MDR Text Key: 264954812
• Report Number: 12273620
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8900-4006
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1