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

Catalog Number 11996-000017

Device Problem Device Sensing Problem (2917)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.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 it was not showing any ecg rhythm with the defibrillation electrodes connected.They were able to get a rhythm when they squeezed the sides where the therapy cable connects to the electrode cable.As a result, defibrillation therapy may have been delayed or unavailable, if needed.There was no report of patient use associated with the reported event.

Manufacturer Narrative

The initial medwatch report was submitted in error and is a duplicate of medwatch report # 0003015876-2020-00819.

Event Description

The customer contacted physio-control to report that they were using their device on a patient and it was not showing any ecg rhythm with the defibrillation electrodes connected.They were able to get a rhythm when they squeezed the sides where the therapy cable connects to the electrode cable.As a result, defibrillation therapy may have been delayed or unavailable, if needed.There was no report 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
• MDR Report Key: 10209450
• MDR Text Key: 197936794
• Report Number: 0003015876-2020-00804
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 00883873784969
• UDI-Public: 00883873784969
• Combination Product (y/n): N
• PMA/PMN Number: K943301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2022
• Device Catalogue Number: 11996-000017
• Device Lot Number: 930842
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIFEPAK® 20E DEFIBRILLATOR/MONITOR, MKJ