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

Model Number	15
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
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 when they attempt to deliver a test shock with the device they have to press the shock button several times.They also reported that the device has an event code logged in its memory.The event code logged is related to a potential failure of the device to deliver defibrillation energy.There was no patient use associated with the reported event.
Event or Problem Description
The customer contacted physio-control to report that when they attempt to deliver a test shock with the device they have to press the shock button several times.They also reported that the device has an event code logged in its memory.The event code logged 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
Physio-control evaluated the customer's device and verified the reported issue.Physio replaced the device's main keypad assembly to resolve the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.Physio-control further evaluated the removed main keypad assembly and determined that the cause of the reported issue was due to the shock switch located on the main keypad assembly was out of tolerance due to excessive resistance.When this issue occurs, an event code will be logged in the device's memory following a failure of the device to deliver defibrillation energy.
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 when they attempt to deliver a test shock with the device they have to press the shock button several times.They also reported that the device has an event code logged in its memory.The event code logged 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® 15 DEFIBRILLATOR/MONITOR
• 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: 8476518
• Report Number: 0003015876-2019-00573
• Device Sequence Number: 13933310
• Product Code: MKJ
• UDI-Device Identifier: 00883873911778
• UDI-Public: 00883873911778
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Notification
• Type of Report: Initial,Followup,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: 99577-001242
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 06/25/2019; 11/18/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 07/18/2019; 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