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

Catalog Number	11101-000021
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker 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 stryker to report that their electrodes were not recognized by any of their devices.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.
Additional Manufacturer Narrative
Stryker evaluated the customer's electrodes and verified the reported issue.Stryker determined that the cause of the reported issue was due to the electrode tray having corrupted eeprom data.The electrodes were archived by stryker and the customer received replacement electrodes.
Event or Problem Description
The customer contacted stryker to report that their electrodes were not recognized by any of their devices.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 ELECTRODE
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 19416347
• Report Number: 0003015876-2024-01758
• Device Sequence Number: 19649309
• Product Code: DRX
• UDI-Device Identifier: 00883873867808
• UDI-Public: 00883873867808
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K943301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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: Lay User/Patient
• Device Catalogue Number: 11101-000021
• Device Lot Number: 230313-3699
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIFEPAK® 15 DEFIBRILLATOR/MONITOR, MKJ.
• Patient Sex: Unknown