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 07/21/2022

Event Type  malfunction  

Manufacturer Narrative

Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.The cause of the reported issue could not be conclusively determined.The electrodes used during reported event are not available for evaluation.Electrodes disposed of by customer.

Event Description

The customer contacted stryker to report that their defibrillation electrodes did not connect to their device as expected.In this state the device would be inoperable and defibrillation therapy would not be available if needed.This issue is patient related; however there was no adverse event reported.

Manufacturer Narrative

Stryker received additional patient information from the customer.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.Concomitant products grid updated with concomitant device serial number: (b)(6).

Event Description

The customer contacted stryker to report that their defibrillation electrodes did not connect to their device as expected.In this state the device would be inoperable and defibrillation therapy would not be available if needed.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: 15212354
• MDR Text Key: 302875075
• Report Number: 0003015876-2022-01858
• Device Sequence Number: 1
• Product Code: DRX
• 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: Foreign
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• 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: 11996-000091
• Device Lot Number: 209423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2022
• 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® 20E DEFIBRILLATOR/MONITOR, MKJ; LIFEPAK® 20E DEFIBRILLATOR/MONITOR, MKJ, 32188875
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic