MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 EDGE SYSTEM ELECTRODES; EXTERNAL PACING/DEFIBRILLATION/ECG ELECTRODES

Catalog Number	11996-000091
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control will not request any patient identifying information to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.Physio-control contacted the customer to request additional information on the patient.The customer informed physio-control that no further patient information is available.Patient fields in which information is not provided were intentionally left blank.   the electrodes used during reported event are not available for evaluation.
Event or Problem Description
A customer contacted physio-control to report that their defibrillation electrodes did not work during intervention on a patient.In this state the device may not be able to provide defibrillation therapy if it were needed.This issue is patient related; however there was no adverse patient outcome reported.

• Brand Name: EDGE SYSTEM ELECTRODES
• Common Device Name: EXTERNAL PACING/DEFIBRILLATION/ECG ELECTRODES
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 11576247
• Report Number: 0003015876-2021-00645
• Device Sequence Number: 11662492
• Product Code: MKJ
• UDI-Device Identifier: 00883873784945
• UDI-Public: 00883873784945
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K960329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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 Catalogue Number: 11996-000091
• Device Lot Number: 019932
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1