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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 10818085
• Report Number: 0003015876-2020-01687
• Device Sequence Number: 3525206
• Product Code: DRX
• UDI-Device Identifier: 00883873784945
• UDI-Public: 00883873784945
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K943301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 11996
• Device Catalogue Number: 11996-000091
• Device Lot Number: 4828
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 11/10/2020; 08/16/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 11/12/2020; 08/18/2021
• 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 20 DEFIBRILLATOR/MONITOR, MKJ, SN (B)(6); LIFEPAK DEFIBRILLATOR/MONITOR, MKJ; LIFEPAK DEFIBRILLATOR/MONITOR, MKJ
• Patient Age: 60 YR