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

Model Number 11996

Device Problem Failure to Sense (1559)

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

Event Date 10/20/2022

Event Type  malfunction  

Event Description

The customer contacted stryker to report that their electrodes did not work as expected.In this state the device would be inoperable and defibrillation therapy would not be available if needed.They were able to open to successfully use another set of electrodes.This issue is patient related; however there was no adverse event reported.

Manufacturer Narrative

The device was not returned to stryker for evaluation.The cause of the reported issue could not be determined.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.Device not returned to manufacturer.

• 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: 16131185
• MDR Text Key: 307603181
• Report Number: 0003015876-2023-00037
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 00883873784969
• UDI-Public: 00883873784969
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K943301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: LP 20E DEFIBRILLATOR/MONITOR, MKJ, SN (B)(4)
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White