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

Model Number	11996
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient information in this form was provided by the customer in a medwatch report.Patient fields in which information was not provided were intentionally left blank.Neither the device nor the electrodes were returned to physio-control for evaluation.The cause of the reported issue could not be determined.
Event or Problem Description
The custom contacted physio-control to report that they were using their device on a patient and the defibrillation electrodes were not being picked up by the device and the device gave a message to apply them.The users confirmed proper electrode connection and power cycled the device, but the issue was not resolved.A 2nd set of electrodes was obtained and used, which resolved the connection issue.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: 11732600
• Report Number: 0003015876-2021-00932
• Device Sequence Number: 17250068
• Product Code: DRX
• UDI-Device Identifier: 00883873784938
• UDI-Public: 00883873784938
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/27/2021

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: No Information
• Device Expiration Date: 07/13/2023
• Device Model Number: 11996
• Device Catalogue Number: 11996-000090
• Device Lot Number: 103642
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 113