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	Cardiac Arrest (1762)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control contacted the customer to request additional information on the patient and device.The customer provided physio-control with the available patient and device information.Patient and device fields in which information is not provided were intentionally left blank.   physio was made aware by the customer that the electrodes used during the event were disposed of.The device or electrodes were not returned to physio-control for evaluation.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.
Event or Problem Description
The customer contacted physio-control to report that pediatric defibrillation electrodes would not stick properly to a (b)(6) patient.The customer advised that the paramedics went through 3 sets of electrodes before being able to stick correctly to the patient.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.This issue is patient related; however there was no adverse event reported.The customer ems assistant cheif matt waltrip confirmed there was no serious injury or death related to the use of the device.
Additional Manufacturer Narrative
The customer provided physio-control with additional concomitant product information, section d has been updated appropriately.
Event or Problem Description
The customer contacted physio-control to report that pediatric defibrillation electrodes would not stick properly to a 2 day old patient.The customer advised that the paramedics went through 3 sets of electrodes before being able to stick correctly to the patient.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.This issue is patient related; however there was no adverse event reported.The customer ems assistant cheif matt waltrip confirmed there was no serious injury or death related to the use of the device.

• 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: 11332633
• Report Number: 0003015876-2021-00412
• Device Sequence Number: 2713131
• Product Code: DRX
• UDI-Device Identifier: 00883873784952
• UDI-Public: 00883873784952
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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: Health Professional
• Device Model Number: 11996
• Device Catalogue Number: 11996-000093
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIFEPAK® 15 DEFIBRILLATOR/MONITOR SN 46620191; LIFEPAK® 15DEFIBRILLATOR/MONITOR,MKJ,SN46620191
• Patient Age: 2 DA
• Patient Weight: 3