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

Model Number 11996

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problems Burn(s) (1757); Ventricular Fibrillation (2130)

Event Date 10/08/2021

Event Type  malfunction  

Manufacturer Narrative

Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

The customer contacted physio-control to report that their device failed to deliver shock while in use with a patient.This issue is patient related; however there was no adverse event reported.

Manufacturer Narrative

Section h5 of initial mfr 0003015876-2021-02037, labeled for single use, states no.Section h5 has been updated to yes.The customer returned all unused electrodes of the same lot to stryker redmond for evaluation.All electrodes performed normally when tested, and no defects in adhesion or gel were detected.The electrodes were applied to the technician's skin for over 2 hours with no adhesion loss or redness when removed.Stryker was unable to replicate issue.No root cause could be determined.

Event Description

The customer contacted physio-control to report that their device failed to deliver shock while in use with a patient.This issue is patient related; however there was no adverse event reported.

• Brand Name: QUIK-COMBO
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 12677592
• MDR Text Key: 277891071
• Report Number: 0003015876-2021-02037
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 00883873784945
• UDI-Public: 00883873784945
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11996
• Device Catalogue Number: 11996-000091
• Device Lot Number: 11999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LIFEPAK 20/20E DEFIBRILLATOR/MONITOR, MKJ