MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number	99401-000210
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control provided the customer with technical assistance and advised the customer that their device is no longer under warranty and there is no repair service for the device.Physio recommended that the customer replace the device and remove from service.The customer confirmed that the device was removed from service.The device and defibrillation electrodes used during the event were not returned to physio-control.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.
Event or Problem Description
The customer, a healthcare provider, contacted physio-control to report that during a patient event their device was unable to detect the patient through the defibrillation electrodes.The customer advised that the device prompted them to ¿connect electrodes¿ when the defibrillation electrodes were connected to the patient.The same defibrillation electrodes were connected to backup aed that was on the scene, and the that device worked properly.It is unknown if skin prep was performed prior to applying the defibrillation electrodes.The customer also advised that the defibrillation electrodes were not expired.The patient, a (b)(6) year old male did not survive.The customer, a health care provider advised that the device use did not contribute to the patient outcome, but was due to the patient's condition.

• Brand Name: LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 8589236
• Report Number: 0003015876-2019-00801
• Device Sequence Number: 16528370
• Product Code: MKJ
• UDI-Device Identifier: 00721902172557
• UDI-Public: 00721902172557
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K052057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2019

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: Health Professional
• Device Catalogue Number: 99401-000210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 05/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR