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

Model Number	EXPRESS
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	Death (1802)
Date of Event	03/06/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).Physio-control downloaded the electronic patient record from the customer's device.However, the record was dated from 2014 and physio confirmed that the time and date in the device was correct.Therefore, the record is not related to the reported event.Physio performed a clinical review of the reported patient event and was unable to determine if the device use contributed to the patient outcome.This was because of insufficient information available, due to the lack of the patient ecg record for the event to determine if the ecg rhythm was shockable.Physio-control 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 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 one of their police unit's device kept repeating itself, "pull the red handle and attach the pads as described." the customer indicated that the handle had already been pulled and the defibrillation electrodes were attached to the patient, and the attachment was checked.The fire department/ems arrived very soon after the police and removed the customer's device and its defibrillation electrodes and connected the patient to their own defibrillator.After the event the customer's device displayed, "ok".Ems was able to get a pulse at the scene after cpr, but the patient a (b)(6) male with family history of cardiac arrest passed later at the hospital.
Additional Manufacturer Narrative
Physio-control further evaluated the customer¿s device but was unable to duplicate the reported issue.After observing proper device operation through functional and performance testing the device was returned to the customer for use.The cause of the reported issue could not be determined.
Event or Problem Description
The customer 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 one of their police unit's device kept repeating itself, "pull the red handle and attach the pads as described." the customer indicated that the handle had already been pulled and the defibrillation electrodes were attached to the patient, and the attachment was checked.The fire department/ems arrived very soon after the police and removed the customer's device and its defibrillation electrodes and connected the patient to their own defibrillator.After the event the customer's device displayed, "ok".Ems was able to get a pulse at the scene after cpr, but the patient a (b)(6) year old male with family history of cardiac arrest passed later at the hospital.

• Brand Name: LIFEPAK EXPRESS(R) 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: 8471604
• Report Number: 0003015876-2019-00559
• Device Sequence Number: 1062543
• Product Code: MKJ
• UDI-Device Identifier: 00883873823811
• UDI-Public: 00883873823811
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K033275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2019

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: Other
• Device Model Number: EXPRESS
• Device Catalogue Number: 80427-000134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 57 YR
• Patient Weight: 79