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

Model Number 11996

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2022

Event Type  malfunction  

Manufacturer Narrative

Stryker contacted the customer to request additional information on the patient.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.Stryker 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 stryker to report that their defibrillation pads did not deliver shock on two attempts during patient use.The customer further advised new lot of defibrillation pads were used and shock successfully delivered to patient.This issue is patient related; however there was no adverse event reported.

Manufacturer Narrative

Stryker evaluated customer's electrodes from the same lot and was unable to verify or duplicate the reported issue.The cause of the reported issue could not be conclusively determined.The customer has been provided with replacement electrodes.The returned electrodes have been archived by stryker.

Event Description

The customer contacted stryker to report that their defibrillation pads did not deliver shock on two attempts during patient use.The customer further advised new lot of defibrillation pads were used and shock successfully delivered to 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: 15591453
• MDR Text Key: 301772142
• Report Number: 0003015876-2022-02264
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 00883873784969
• UDI-Public: 00883873784969
• 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: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• 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: 11996-000017
• Device Lot Number: 221684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LIFEPAK® 20E DEFIBRILLATOR/MONITOR, MKJ
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 90 KG