MAUDE Adverse Event Report: ZOLL ZOLL; PRO-PADS ADULT MULTIFUNCTION

Lot Number 5117A

Device Problems Flare or Flash (2942); Noise, Audible (3273)

Patient Problem Skin Discoloration (2074)

Event Date 01/22/2018

Event Type  malfunction  

Event Description

Staff reported a loud popping sound and noted a flash from an anterior pad during cardioversion.Staff reported skin was light pink underneath where the pad was, with a dark pink mark where the inner pad has an edge.

• Brand Name: ZOLL
• Type of Device: PRO-PADS ADULT MULTIFUNCTION
• Manufacturer (Section D): ZOLL; chelmsford MA
• MDR Report Key: 7221573
• MDR Text Key: 98468028
• Report Number: MW5074892
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 0084794601661
• UDI-Public: (01)0084794601661
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/23/2018

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 Lot Number: 5117A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2018
• 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 Age: 74 YR
• Patient Weight: 71