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

Model Number	15
Medical Device Problem Code	Failure To Run On AC/DC (1001)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control performed an initial evaluation of the customer's device and verified the reported issue.Physio-control continues to investigate the reported issue 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 the on button on their device would only respond intermittently when pressed.The customer further advised their device powered off by itself during an event.There were no reports of adverse effects to the patient as a result of the reported issue.Physio-control has attempted to contact the customer in order to obtain additional information about the patient and the event; however, no response has been received.
Additional Manufacturer Narrative
Physio-control confirmed that the customer uses their device in an ambulance with an ac power adapter (acpa) connected to inverter power.The make and model of the inverter was unknown as there were no labels on the inverter.Physio-control determined that the cause of the reported issue was due to the acpa assembly.Physio-control observed that the acpa power light would blink on and off when the reported power issues were observed.Physio-control replaced the acpa to resolve the reported issue and after observing proper device operation through functional and performance testing the unit was returned to the customer for use.Physio-control had downloaded the electronic records from the device for review.Physio-control observed that it did not include any data from the date of the reported patient event.However, physio-control did observe that the data showed a significant amount of unusual rapid and repeated power switching behavior (switching from batt 2 to the acpa, from the acpa to batt2, from batt 2 to batt 1, from batt 1 to the acpa, etc.).This behavior is consistent with what physio-control observed when the device was evaluated along with the acpa used during the reported event.Physio-control further evaluated the returned acpa where the reported issue was confirmed.The acpa power light (the "light bar") were observed to blink continuously.After "manipulating" the acpa, the power light remained on steady and 12 volts dc was measured at the output connector (note: with a functional acpa, the power light remains on steady when connected to ac power).Physio-control determined that the likely cause of the reported issue was due to the acpa that was connected to the device during the event.A failure of the acpa can result in a failure to maintain the charge on the device¿s batteries.A failure of the acpa in combination with the use of the acpa on a vehicle power inverter (specifically a modified sine wave inverter) has previously been associated with an intermittent inability to turn the device on and an unexpected loss of power.
Event or Problem Description
The customer contacted physio-control to report that the on button on their device would only respond intermittently when pressed.The customer further advised their device powered off by itself during an event.There were no reports of adverse effects to the patient as a result of the reported issue.Physio-control has attempted to contact the customer in order to obtain additional information about the patient and the event; however, no response has been received.
Event or Problem Description
The customer contacted physio-control to report that the on button on their device would only respond intermittently when pressed.The customer further advised their device powered off by itself during an event.There were no reports of adverse effects to the patient as a result of the reported issue.Physio-control has attempted to contact the customer in order to obtain additional information about the patient and the event; however, no response has been received.
Additional Manufacturer Narrative
Section d4 of the initial medwatch report indicates: gtin/device identifier (di) number ¿ blank section d4 of the initial medwatch report should indicate: gtin/device identifier (di) number ¿ (b)(4).

• 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: 7503396
• Report Number: 0003015876-2018-00749
• Device Sequence Number: 18875946
• Product Code: MKJ
• UDI-Device Identifier: 00883873872017
• UDI-Public: 00883873872017
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2020

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: 99577-001938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 08/13/2018; 02/25/2020
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 08/29/2018; 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1