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

Model Number 11996

Device Problem Failure to Sense (1559)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

The customer has submitted voluntary event report mw5096816 regarding this event.Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

The customer contacted physio-control to report that their device would not sense rhythm or heart rate while quik-combo electrodes were in use.There was no patient use reported with the event.

Manufacturer Narrative

Physio-control contacted the customer to request additional information on the patient.The customer provided physio-control with the available patient information, and it has been added to section a.Patient fields in which information is not provided were intentionally left blank.  additionally, the device serial number was added to section d10.

Event Description

The customer contacted physio-control to report that their device would not sense rhythm or heart rate while quik-combo electrodes were in use.There was no patient use reported with the event.

Event Description

The customer contacted physio-control to report that their device would not sense rhythm or heart rate while quik-combo electrodes were in use.There was no patient use reported with the event.

Manufacturer Narrative

The customer informed physio-control that the issue has been resolved, and the device does not need to be returned for further evaluation.The reported issue was unable to be verified and unable to be duplicated.Root cause is unable to be determined.H3 other text: device not returned.

• 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: 10818085
• MDR Text Key: 215572779
• Report Number: 0003015876-2020-01687
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 00883873784945
• UDI-Public: 00883873784945
• Combination Product (y/n): N
• PMA/PMN Number: K943301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2021

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
• Device Operator: Health Professional
• Device Model Number: 11996
• Device Catalogue Number: 11996-000091
• Device Lot Number: 4828
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 11/10/2020; 08/16/2021
• Supplement Dates FDA Received: 11/12/2020; 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIFEPAK 20 DEFIBRILLATOR/MONITOR, MKJ, SN (B)(6); LIFEPAK DEFIBRILLATOR/MONITOR, MKJ; LIFEPAK DEFIBRILLATOR/MONITOR, MKJ
• Patient Age: 60 YR