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	No Patient Involvement (2645)
Date of Event	02/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and was unable to duplicate the reported issue.The device was opened, and then an internal physical inspection was performed.No discrepancies were observed.The device did analyze, charge, and shock.Physio replaced the therapy connector as a precaution.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.The electrodes were not returned to physio-control for an evaluation.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted physio-control to report that their device would not recognize a patient connection.The device continued to give the connect electrodes prompt even after the electrodes were properly attached to the patient.The customer reported that the patient expired; however, it was not due to the reported issue.The patient had a do not resuscitate order.
Event or Problem Description
The customer contacted physio-control to report that their device would not recognize a patient connection.The device continued to give the connect electrodes prompt even after the electrodes were properly attached to the patient.The customer reported that the patient expired; however, it was not due to the reported issue.The patient had a do not resuscitate order.
Additional Manufacturer Narrative
Physio-control further evaluated the removed therapy connector assembly and determined that the root cause of the reported issue was 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.

• 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: 8430180
• Report Number: 0003015876-2019-00472
• Device Sequence Number: 16192533
• 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: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2019

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: 99401-001084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR