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

Catalog Number	99401-001084
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Death (1802)
Date of Event	07/01/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).Physio-control continues to investigate the reported failure 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 they were using this device on a patient and it displayed a ¿connect electrodes¿ message.This led to over a 6 minute delay in the treatment of the patient.As a result, defibrillation therapy may have been delayed or unavailable, if it was needed.The patient involved in the reported event is deceased.
Event or Problem Description
The customer contacted physio-control to report that they were using this device on a patient and it displayed a connect electrodes¿ message.This led to over a 6 minute delay in the treatment of the patient.As a result, defibrillation therapy may have been delayed or unavailable, if it was needed.The patient involved in the reported event is deceased.
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and was unable to duplicate the reported issue.Physio replaced the device's therapy connector as a precautionary measure.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Physio-control further evaluated the removed therapy connector and verified the reported issue.Physio determined that the cause of the reported issue was due to worn contacts.The contacts had mechanical wear-through of the contact plating which exposes underlying nickel and copper layers.These layers can then form an oxide layer that increases the contact resistance and in turn the electrical impedance of the connector.An electrical impedance that is too high will cause the device to not recognize a patient and give the "connect electrodes" message.
Event or Problem Description
The customer contacted physio-control to report that they were using this device on a patient and it displayed a ¿connect electrodes¿ message.This led to over a 6 minute delay in the treatment of the patient.As a result, defibrillation therapy may have been delayed or unavailable, if it was needed.The patient involved in the reported event is deceased.
Additional Manufacturer Narrative
Section b2 death date of the initial medwatch report was blank.Section b2 death date of the initial medwatch report should indicate: (b)(6) 2019.

• 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: 8878773
• Report Number: 0003015876-2019-01326
• Device Sequence Number: 2028755
• Product Code: MKJ
• UDI-Device Identifier: 00885074753980
• UDI-Public: 00885074753980
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2020

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: 99401-001084
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 12/19/2019; 02/08/2020
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 01/09/2020; 03/04/2020
• 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: 62 YR
• Patient Weight: 110