MAUDE Adverse Event Report: KATECHO, INCORPORATED PP:TRANSPARENT ECG/DEFIB PAD; PADPRO:DEFIB PADS

Catalog Number 2001.

Device Problems Thermal Decomposition of Device (1071); Sparking (2595)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The reported device location is currently uncertain.Additional information about the event and alleged "patient injury" is still being collected.A supplemental report will be filed following the completion of the complaint investigation.

Event Description

The customer reported "the pad sparked when the defibrillator machine charged and the pad scorched".The patient was allegedly injured, however, despite several attempts, additional information regarding the event and patient have not been made available.This report is raised on the basis of a reported device malfunction with potential for injury with recurrence.

Manufacturer Narrative

Three pads with unknown lot numbers were initially reported to have been used on three different patients [mdr 1320894-2018-00010 mdr 1320894-2018-00011 mdr 1320894-2018-00012].Additional information provided by the facility revealed these three devices were used on one patient during one event.The supplemental report for this device will be captured in mdr 1320894-2018-00010.

• Brand Name: PP:TRANSPARENT ECG/DEFIB PAD
• Type of Device: PADPRO:DEFIB PADS
• Manufacturer (Section D): KATECHO, INCORPORATED; 2500 bell ave; des moines IA 50321
• MDR Report Key: 7183646
• MDR Text Key: 97017569
• Report Number: 1320894-2018-00012
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K014209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

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 Catalogue Number: 2001.
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 01/11/2018
• Supplement Dates Manufacturer Received: 01/17/2018
• Supplement Dates FDA Received: 01/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1