MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 ELECTRODES, 5-YEAR, LPCR2; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	11103
Medical Device Problem Code	Arcing of Electrodes (2289)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/25/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device evaluation is anticipated, but has not yet begun.Photographs were provided and reviewed by stryker customer quality engineers.The photographs provided indicate melting on the corner of one of the electrodes, but do not indicate flames.A clinical review of the event was performed.There is no device data or sufficient reported information to determine device contribution to the reported outcome.In the medical judgment of these reviewers, it is unknown if the device caused or contributed to a serious injury or death.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 there were electric arcs on the electrodes that burned the patient and emitted flames.This issue has the potential to either delay, or prevent, defibrillation from being delivered.The patient associated with the reported event did not survive.The customer noted that user error is suspected in this event.
Additional Manufacturer Narrative
Stryker evaluated the customer's device and was unable to duplicate or verify the reported issue.The electrodes that were involved in the event were not returned for evaluation.The device that was returned passed performance and functional testing and was returned to the customer.The root cause for the burned electrode is undetermined.
Event or Problem Description
The customer contacted stryker to report that there were electric arcs on the electrodes that burned the patient and emitted flames.This issue has the potential to either delay, or prevent, defibrillation from being delivered.The patient associated with the reported event did not survive.The customer noted that user error is suspected in this event.
Event or Problem Description
The customer contacted stryker to report that there were electric arcs on the electrodes that burned the patient and emitted flames.This issue has the potential to either delay, or prevent, defibrillation from being delivered.The patient associated with the reported event did not survive.The customer noted that user error is suspected in this event.
Additional Manufacturer Narrative
Correction to initial mfr report number 0003015876-2023-00331: death date: indicated blank death date should indicate: (b)(6) 2023.

• Brand Name: ELECTRODES, 5-YEAR, LPCR2
• 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: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 16411584
• Report Number: 0003015876-2023-00331
• Device Sequence Number: 5743075
• Product Code: MLN
• UDI-Device Identifier: 00883873871577
• UDI-Public: 00883873871577
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P170018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 11103
• Device Catalogue Number: 11103-000026
• Device Lot Number: 210823-3694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 05/24/2023; 08/30/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 06/22/2023; 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2021
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown