MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 1000 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	1000
Medical Device Problem Codes	Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A stryker service representative performed evaluation of the customer¿s device and was not able to duplicate the reported issue.A customer quality engineer (cqe) evaluated the device electronic records.The cqe first evaluated the pco file for the event that began at 9:39am.The device completed one rhythm analysis during the event.It was determined that the ecg rhythm had sufficient isoelectric baseline content and apparent qrs complexes, so a no shock advised determination was made.The cqe next evaluated the pco file for the event that began at 10:41am.The device completed three rhythm analyses during the event.During analysis 1 and 2, it was determined that the ecg rhythm had sufficient isoelectric baseline content and apparent qrs complexes, so no shock advised determinations was made.During analysis 3, it was determined that there was enough absence of an isoelectric signal and adequate signal amplitude, so a shock advised determination was made.The user then proceeded to deliver a shock to the patient.It was not observed in either pco file that a shock was not delivered after a shock advised determination was made as the customer reported.In both events the shock advisory algorithm functioned correctly.The reported issue was unable to be verified.Proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.A cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted stryker to report that their device gave incorrect shock advisory in aed mode during intervention on a patient.The device indicated normal sinus rhythm but a shock was advised.In this state, wrong defibrillation therapy may be delivered.This issue is patient related; however there was no adverse patient outcome reported.
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 their device gave incorrect shock advisory in aed mode during intervention on a patient.The device indicated normal sinus rhythm but a shock was advised.In this state, wrong defibrillation therapy may be delivered.This issue is patient related; however there was no adverse patient outcome reported.

• Brand Name: LIFEPAK(R) 1000 DEFIBRILLATOR
• 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: 19114029
• Report Number: 0003015876-2024-00804
• Device Sequence Number: 15366443
• Product Code: MKJ
• UDI-Device Identifier: 00883873815465
• UDI-Public: 00883873815465
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P160026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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 Model Number: 1000
• Device Catalogue Number: 99425-000025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2022
• 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
• Patient Sex: Unknown