MAUDE Adverse Event Report: KATECHO, INCORPORATED PP:PMS HS PLUG;TRANSPARENT; PADPRO:DEFIB PADS:PHILIPS PLUG

Model Number	2001H
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used device was returned to conmed for evaluation in opened original packaging.Visual inspection of the device found that the pads were folded together.The pads were tested for continuity and shock delivery.The pads met specifications.A review of the manufacturing documents verified the device was produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified at the time of manufacture.A review of this lot number showed no other complaint for this lot product and event description.A two-year review of complaint history revealed 11 other similar complaints, with 14 devices, for this product family and failure mode.In that same timeframe, (b)(4) units of this product family have been sold worldwide, making the rate of occurrence of this failure (b)(4) percent.The instructions for use advises the user of the following.- do not apply any substance to the skin surface that will leave a residue, i.E.Lotions, oils, etc.- if the electrodes do not adhere properly to the patient, apply a new pair.- do not re-apply if removed.- ensure that the skin is clean and dry, clipping excess hair.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The conmed sales representative reported on behalf of the user facility that during a cardioversion, the 2001h pads were not shocking.The procedure was completed with a 10 minute delay and with an alternate device.No patient injury was reported.This report is being raised on the basis of a reported malfunction with potential for injury with recurrence.

• Brand Name: PP:PMS HS PLUG;TRANSPARENT
• Common Device Name: PADPRO:DEFIB PADS:PHILIPS PLUG
• Manufacturer (Section D): KATECHO, INCORPORATED; 2500 bell avenue; des moines IA 50321
• MDR Report Key: 7559228
• Report Number: 1320894-2018-00136
• Device Sequence Number: 13811271
• Product Code: MKJ
• UDI-Device Identifier: 10653405064282
• UDI-Public: (01)10653405064282(17)210302(10)Y03011817
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/31/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2021
• Device Model Number: 2001H
• Device Catalogue Number: 2001H
• Device Lot Number: Y03011817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1