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

Model Number	11996
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/12/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 9803189
• Report Number: 0003015876-2020-00336
• Device Sequence Number: 586222
• Product Code: DRX
• UDI-Device Identifier: 00721902195037
• UDI-Public: 00721902195037
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K943301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1