MAUDE Adverse Event Report: KATECHO, INCORPORATED PP:ZOLL DC;MINI,TRANSLUCENT; PADPRO

Model Number	2602Z
Medical Device Problem Code	Failure to Analyze Signal (1539)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to conmed for evaluation with used original packaging.Catalog and lot numbers were verified.Visual inspection of the back pad noted that there was a slight defect in the gel and substrate.Testing of conductivity was conducted on both the front and back pad using a multimeter with no abnormalities observed.The pads were also subjected to iec testing; this testing concluded the pad set did not pass the requirements for large signal impedance.The manufacture, (b)(4), provided lot history record for our review.The review of this document found no-nonconformance's pertaining to the failure mode observed in the complaint.The product test results indicated acceptable product release.A historical review of complaint data revealed a total of 8 similar complaints, with 3 confirmed devices, in the past two years.In the same timeframe, (b)(4) units have been sold worldwide, making the rate of occurrence of this failure (b)(4) percent.A risk analysis was performed and found this failure mode and occurrence to be consistent with current risk documents.The instructions for use advise the user of the following.If the electrodes do not adhere properly to the patient, apply a new pair.Due to the severity of this malfunction, the investigation process has been escalated to a higher level in conmed and at the manufacturer of this device, (b)(4).A ship hold has been initiated to hold suspect padpro inventory until investigation is completed.This issue will continue to be monitored through the complaint system.
Event or Problem Description
A conmed sales representative reported on behalf of the user facility that the padpro pads failed testing.The pads were used on a variety of patients; impedance and troubleshooting were performed as well, but the pads did not function as intended.This incident is not associated with one patient or event.No patient injury was reported.This report is raised on the basis of a reported malfunction with potential for injury with recurrence.

• Brand Name: PP:ZOLL DC;MINI,TRANSLUCENT
• Common Device Name: PADPRO
• Manufacturer (Section D): KATECHO, INCORPORATED; 2500 bell avenue; des moines IA 50321
• MDR Report Key: 7006873
• Report Number: 1320894-2017-00243
• Device Sequence Number: 19115242
• Product Code: MKJ
• UDI-Device Identifier: 10653405042549
• UDI-Public: (01)10653405042549(17)191116(30)1(10)Y11141607
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K002280
• 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): 11/07/2017

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: No Information
• Device Expiration Date: 11/16/2019
• Device Model Number: 2602Z
• Device Catalogue Number: 2602Z
• Device Lot Number: Y11141607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1