MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL DEFRIBULATOR-- PRO PADZ; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number 8900-4006

Device Problem Noise, Audible (3273)

Patient Problem Skin Discoloration (2074)

Event Date 04/20/2022

Event Type  Injury  

Event Description

Mr.(b)(6) is a (b)(6) man with a history of atrial fibrillation, for which he presented for an elective outpatient electrical cardioversion.Mr.(b)(6)'s anterior chest hair was clipped and cleared from the site; no posterior chest hair was present.No alcohol-based fluid, or fluid of any other kind, was used on the skin.The zoll defibrillator pads were then placed in an anterior-posterior vector following the manufacturer's recommendation for placement, including rolling the edges of the pad backward, adhering the pad to the skin from the center, and pressing radially outward in all directions to confirm excellent skin contact and prevent air-pocket formation.The zoll defibrillator was then placed in "defib" mode, with synchronizing turned on and appropriate sensing noted.The defibrillator energy selector was set to 200 j.After sedation was delivered by the anesthesia service and nasal cannula o2 was turned off, one synchronized 200j shock was delivered.Immediately on energy delivery, a brief crisp spark-like sound was audible, though no visible spark was seen.The pads were immediately removed, and the skin that had been making contact with the anterior pad had a thin, 1 mm circle of rust-colored discoloration corresponding to the perimeter of the shocking pad.The skin was not warm to the touch, red, swollen, or broken.The skin on the posterior chest was unaffected.Ice was immediately applied, and mr.(b)(6) awoke feeling fine, without any complaints of pain or discomfort on the anterior chest skin.The events of the cardioversion were explained thoroughly to him and his wife.He was observed with no development of redness, tenderness, swelling, or warmth at this site, and he was discharged with a prescription for silver sulfadiazine 1% cream to be applied bid, instructions for signs for which he should present to the er, and follow-up instructions for this week.Fda safety report id# (b)(4).

• Brand Name: ZOLL DEFRIBULATOR-- PRO PADZ
• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION
• MDR Report Key: 14194922
• MDR Text Key: 290099954
• Report Number: MW5109320
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2023
• Device Model Number: 8900-4006
• Device Lot Number: 0222C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 168 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White