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

Model Number	15
Medical Device Problem Code	Aborted Charge (2288)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/15/2019
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.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted physio-control to report that they were using this device on a patient and the device unexpectedly dumped its defibrillation energy charge.A result, defibrillation therapy may have been delayed or unavailable, if it was needed.There were no reports of any adverse effects to the patient as a result of the reported issue.Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.
Additional Manufacturer Narrative
The customer provided the patient information.Patient information and other relevant history have been updated.The initial medwatch report date of event indicated (b)(6) 2019.The initial medwatch report date of event should indicate (b)(6) 2019.
Event or Problem Description
The customer contacted physio-control to report that they were using this device on a patient and the device unexpectedly dumped its defibrillation energy charge.A result, defibrillation therapy may have been delayed or unavailable, if it was needed.There were no reports of any adverse effects to the patient as a result of the reported issue.Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.
Event or Problem Description
The customer contacted physio-control to report that they were using this device on a patient and the device unexpectedly dumped its defibrillation energy charge.A result, defibrillation therapy may have been delayed or unavailable, if it was needed.There were no reports of any adverse effects to the patient as a result of the reported issue.Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.
Additional Manufacturer Narrative
Physio downloaded the device's electronic records from the event for review and was able to verify the reported issue.It was observed that the customer had pressed the charge button, the charge completed, but 8 seconds later a leads off message was given, indicating that the paddles lead had lost connection, removing the charge.The customer later confirmed that they had been using third party electrodes, which was likely the cause of the reported issue.Per the device's operating instructions; "using other manufacturers¿ cables, electrodes, power adapters, or batteries may cause the device to perform improperly and may invalidate the safety agency certifications.Use only the accessories that are specified in these operating instructions." there is no evidence that a malfunction of the device occurred.

• 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: 8872499
• Report Number: 0003015876-2019-01319
• Device Sequence Number: 2078929
• Product Code: MKJ
• UDI-Device Identifier: 00883873872079
• UDI-Public: 00883873872079
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2019

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: 99577-001932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 08/27/2019; 10/30/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 08/27/2019; 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 97