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

Catalog Number	99401-000840
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Death (1802)
Date of Event	01/09/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).The customer advised physio-control that they performed several tests on this device and observed that it was operating normally without any issues.The device has been returned to service.Physio-control performed a clinical review of the event and concluded that it is unknown whether the device contributed to the outcome of the patient or not as there is no electronic device download from the event to indicate whether the patient's rhythm was shockable.There was also use error as the user failed to adequately prep the patient's skin prior to applying the defibrillation electrodes.The device was not returned to physio-control for evaluation.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.
Event or Problem Description
The customer contacted physio-control to report that their device continuously gave a ¿connect electrodes¿ message and was unable to analyze the patient rhythm.The device was being used on a patient and they had physio-control branded defibrillation electrodes connected to the patient.There was a 12-15 minute delay before ems personnel arrived on the scene with a back-up device.As a result, defibrillation therapy would not have been available, if it was needed.The ems personnel believe the issue was caused by the patient's hairy chest, profuse sweating, and a lack of skin prep performed by the initial responders.Over 30 minutes of cpr was performed on the patient during the event.The ems personnel shaved the patient's chest when they arrived, performed additional skin prep, and were able to get a patient connection and rhythm.The back up device indicated no shock advised.The patient is deceased.The customer doesn't know if the device use contributed to the outcome of the patient since they were unable to analyze the patient's rhythm for 12-15 minutes during the event.

• Brand Name: BIPHASIC LIFEPAK® 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: 8291397
• Report Number: 0003015876-2019-00167
• Device Sequence Number: 1947309
• Product Code: MKJ
• UDI-Device Identifier: 00721902655203
• UDI-Public: 00721902655203
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/30/2019

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: Health Professional
• Device Catalogue Number: 99401-000840
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/30/2019
• 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: 20 YR
• Patient Weight: 109