MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL RADIOLUCENT PAD; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Device Problems Device Emits Odor (1425); Noise, Audible (3273)

Patient Problems Erythema (1840); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 06/08/2021

Event Type  Injury  

Event Description

Patient experienced redness/irritation with slight blistering during cardioversion.Patient was prepped according to manufacturer recommendation and burn did not occur as a result of prepping.Pads initially placed on anterior chest and back per manufacturer recommendations.Pads were applied using rolling technique, which was confirmed by procedure rn during investigation.Good seal and skin contact achieved.Loud popping noise was heard after delivery of 150 joules and team noted burning smell.Pads were removed and skin assessed, slight redness noted where anterior pad was placed but nothing on posterior site.Fda safety report id# (b)(4).

• Brand Name: ZOLL RADIOLUCENT PAD
• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION
• MDR Report Key: 12049758
• MDR Text Key: 258086665
• Report Number: MW5102032
• Device Sequence Number: 1
• Product Code: DTE
• 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: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 65