MAUDE Adverse Event Report: KATECHO INCORPORATED PAD PRO ZOLL DC TRANSPARENT DEFIB PADS; DEFIBRILLATION PADS

Catalog Number	2001Z-C
Medical Device Problem Codes	Unable to Obtain Readings (1516); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation and no photographic evidence has been provided.Therefore, the reported event cannot be verified.A two-year lot history review was conducted and found a total of 3 similar events involving 3 devices for this lot number, however, they haven't been confirmed.A dhr review was provided by vendor katecho and found no abnormalities that would contribute to this reported event.A two-year review of complaint history revealed there has been 14 complaints regarding 52 devices for this device family and failure mode.During the same time frame 29,590 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be.002 per the instructions for use, the user is advised the following; misuse of multifunctional electrodes, use of compromised or altered product, and/ or failure to follow product instructions may result in patient burns, inadequate delivery of therapy, and/ or loss of ecg trace quality.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
During a cabg procedure the pads were placed on patient and the zoll monitor read "bad connection".They brought in a new monitor from a different room and placed same pads on same patient and the monitor gave the same message, "bad connection." biomed checked the monitor and everything checked out to be working properly.They also hooked up a new set of pads and ran it at 30, 50, and 100 joules and it never read "bad connection.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

• Brand Name: PAD PRO ZOLL DC TRANSPARENT DEFIB PADS
• Common Device Name: DEFIBRILLATION PADS
• Manufacturer (Section D): KATECHO INCORPORATED; 2500 bell avenue; des moines, ia
• MDR Report Key: 9719878
• Report Number: 1320894-2020-00029
• Device Sequence Number: 367267
• Product Code: MKJ
• UDI-Device Identifier: 20653405042485
• UDI-Public: (01)20653405042485(17)221121(10)Y11211904
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K014209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/18/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/21/2022
• Device Catalogue Number: 2001Z-C
• Device Lot Number: Y11211904
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1