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

Model Number 11996

Device Problem Failure to Sense (1559)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/12/2020

Event Type  malfunction  

Manufacturer Narrative

Physio-control contacted the customer to request additional information on the patient.The customer informed physio-control that no further patient information is available.Patient fields in which information was not provided were intentionally left blank.The device was not returned to physio-control for evaluation.The cause of the reported issue could not be determined.

Event Description

The customer contacted physio-control to report that they were using their device on a patient and the defibrillation electrodes were not working correctly and failed to pick up an ecg rhythm through the paddles lead.Another set of defibrillation electrodes were obtained and these also failed to pick up the patient's ecg rhythm through the paddles lead.The last set of defibrillation electrodes were obtained and worked normally and the users were able to monitor the patient and continue patient care.There were no reports of any adverse effects to the patient as a result of the reported issue.

• 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: 9803189
• MDR Text Key: 189591715
• Report Number: 0003015876-2020-00336
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 00721902195037
• UDI-Public: 00721902195037
• 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: Other
• Type of Report: Initial
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2021
• Device Model Number: 11996
• Device Catalogue Number: 11996-000090
• Device Lot Number: 910519
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1