MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 QUIK-COMBO; ELECTRODE, ELECTROCARDIOGRAPH

Catalog Number 11996-000017

Device Problem Device Sensing Problem (2917)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

Physio-control contacted the customer to request additional information on the patient.The customer informed physio-control that no further patient information is available.The device was not returned to physio-control for evaluation.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.

Event Description

The customer contacted physio-control to report that their device was intermittently not reading an ecg signal through the paddles lead.The customer advised that when the connection between the defibrillation therapy cable and the defibrillation electrodes was manipulated a signal was obtained.The customer advised several defibrillation electrodes exhibited this issue.Without this functionality the need for defibrillation therapy would be able to be determined.This issue is patient related; however there was no adverse patient outcome reported.

Manufacturer Narrative

Physio-control evaluated the customer's device that was used with the defibrillation electrodes for the reported issue.Physio did not find a problem with the device.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.Physio did observe that the customer's ecg leads were 9 years past expiry, and the defibrillation therapy cable assembly was also past expiry.Per the lifepak 20e operating instructions, "cables and paddles are a critical part of therapy delivery and suffer wear and tear.Physio-control recommends replacement of these accessories every three years to reduce the possibility of failure during patient use." the customer received new ecg and defibrillation therapy cables.The defibrillation electrodes used during the event was not returned to physio for evaluation.The likely cause of the reported issue was due to the user failing to replace the parts per the product operating instructions, however a conclusive could not be determined.

Event Description

The customer contacted physio-control to report that their device was intermittently not reading an ecg signal through the paddles lead.The customer advised that when the connection between the defibrillation therapy cable and the defibrillation electrodes was manipulated a signal was obtained.The customer advised several defibrillation electrodes exhibited this issue.Without this functionality the need for defibrillation therapy would be able to be determined.This issue is patient related; however there was no adverse patient outcome reported.

• Brand Name: QUIK-COMBO
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 10171857
• MDR Text Key: 197291573
• Report Number: 0003015876-2020-00771
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 00883873784969
• UDI-Public: 00883873784969
• Combination Product (y/n): N
• PMA/PMN Number: K943301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11996-000017
• Device Lot Number: 922451
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIFEPAK 20E; LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR, MKJ,SN:UNK