MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	15
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/05/2018
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.Physio observed that the reported event code was logged on a previous date, but was not repeatable.Physio replaced the main keypad assembly as a precaution.After other unrelated repairs were completed, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Physio further evaluated the removed main keypad assembly in a test device and verified the reported issue.The shock switch measured a high resistance which caused the reported issue.
Event or Problem Description
The customer contacted physio-control to report that their device was unable to deliver defibrillation energy.The customer advised, that when the shock button was pressed to deliver the energy, the device would disarm and dump the energy charge internally.The customer indicated that this happened consistently at the 100, 300 and 360 joule settings, and intermittently at 200 joules.When this occurred their device service indicator was illuminated and their device logged an event code in the device¿s memory that is related to a potential failure of the device to deliver defibrillation energy.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
This product complaint requires a supplemental mdr to document that field action number 301587611/18/2019-001c is relevant to the reported issue.
Event or Problem Description
The customer contacted physio-control to report that their device was unable to deliver defibrillation energy.The customer advised, that when the shock button was pressed to deliver the energy, the device would disarm and dump the energy charge internally.The customer indicated that this happened consistently at the 100, 300 and 360 joule settings, and intermittently at 200 joules.When this occurred their device service indicator was illuminated and their device logged an event code in the device¿s memory that is related to a potential failure of the device to deliver defibrillation energy.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 15 MONITOR/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: 8020394
• Report Number: 0003015876-2018-01812
• Device Sequence Number: 16502528
• Product Code: MKJ
• UDI-Device Identifier: 00883873911815
• UDI-Public: 00883873911815
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2019

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 Model Number: 15
• Device Catalogue Number: 99577-001238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Initial Date Received by Manufacturer: 10/05/2018
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3015876-11/18/2019-001C
• Patient Sequence Number: 1