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

Catalog Number 11101-000021

Device Problems Electrical /Electronic Property Problem (1198); Failure to Sense (1559)

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

Event Date 10/24/2022

Event Type  malfunction  

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.

Event Description

A customer contacted stryker to report that the device would not detect the electrodes being connected.As a result, defibrillation therapy would not be available, if needed.There were no reports of patient use associated with the reported event.

Manufacturer Narrative

Stryker evaluated the customer's device and was unable to duplicate the issue of the electrodes not connecting correctly with the device.Upon inspection, it was observed that the device kept resetting after the lid is opened.The device can no longer be repaired.The customer was provided with a replacement device.The cause of the reported issue could not be determined.

Event Description

A customer contacted stryker to report that the device would not detect the electrodes being connected.As a result, defibrillation therapy would not be available, if needed.There were no reports of patient use associated with the reported event.

• 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: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 17403530
• MDR Text Key: 319855117
• Report Number: 0003015876-2023-01338
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 00883873867808
• UDI-Public: 00883873867808
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11101-000021
• Device Lot Number: 210210-3698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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