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

Catalog Number 11996-000091

Device Problem Arcing of Electrodes (2289)

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

Event Date 12/12/2023

Event Type  malfunction  

Event Description

The customer contacted stryker to report "a pop and small puff of smoke" while in use with a patient.This could prevent or delay defibrillation.There was no adverse event reported due to this event.

Manufacturer Narrative

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.Stryker 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.

• 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 18619769
• MDR Text Key: 334280990
• Report Number: 0003015876-2024-00224
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873784945
• UDI-Public: 00883873784945
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11996-000091
• Device Lot Number: 309710
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1