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

Model Number 20E

Device Problem Sparking (2595)

Patient Problems Atrial Flutter (1730); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2023

Event Type  Injury  

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 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 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.

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.

• Brand Name: LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR
• Type of Device: 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
• MDR Text Key: 325304083
• Report Number: 0003015876-2023-01857
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

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
• Device Operator: Health Professional
• Device Model Number: 20E
• Device Catalogue Number: 99507-000106
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 101 KG