MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	20E
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Codes	Atrial Flutter (1730); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker contacted the customer to request additional information on the patient.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.   stryker continues to investigate the reported issue 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 during intervention on a patient their device sparked and cause the serious injury to the patient.The two thermal burns were found on the patient's chest after intervention.
Event or Problem Description
The customer contacted stryker to report that during intervention on a patient their device sparked and cause the serious injury to the patient.The two thermal burns were found on the patient's chest after intervention.
Additional Manufacturer Narrative
Section dh6 clinical signs code grid of initial mdr indicates: atrial flutter.Section dh6 clinical signs code grid of initial mdr should indicate: no clinical signs, symptoms or conditions.The customer's device and electrodes are not returned to stryker for the evaluation.A cause of the reported issue could not be determined.H3 other text : device not returned.
Additional Manufacturer Narrative
Corrected data: section d4 gtin of the initial medwatch report indicates: blank.Section d4 gtin of the initial medwatch report should have indicated: (b)(4).
Event or Problem Description
The customer contacted stryker to report that during intervention on a patient their device sparked and cause the serious injury to the patient.The two thermal burns were found on the patient's chest after intervention.

• Brand Name: LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• 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: 17906407
• Report Number: 0003015876-2023-01857
• Device Sequence Number: 7777278
• Product Code: MKJ
• UDI-Device Identifier: 00883873887660
• UDI-Public: 00883873887660
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2024

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: Health Professional
• Device Model Number: 20E
• Device Catalogue Number: 99507-000106
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 01/22/2024; 09/30/2024
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 02/07/2024; 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2016
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Other
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 101 KG