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

Model Number	15
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information was not provided were intentionally left blank.Physio-control evaluated the customer's device and verified the reported issue.Physio replaced the device's battery contact pcb assembly and battery pins.Physio also tightened the nuts on the back of the battery pins and cleaned and reseated the connectors that plug into the power pcb assembly.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.
Event or Problem Description
The customer contacted physio-control to report that their device unexpectedly powered off multiple times during a patient event.There were no reports of any adverse effects to the patient as a result of the reported issue.
Event or Problem Description
The customer contacted physio-control to report that their device unexpectedly powered off multiple times during a patient event.There were no reports of any adverse effects to the patient as a result of the reported issue.
Additional Manufacturer Narrative
Physio downloaded the device's electronic records from the event for review and was verified the reported issue.
Additional Manufacturer Narrative
The customer contacted physio-control to provide the patient information for the patient that was involved in the reported event.Fields a1, a2, a3, and a4 have been updated.The customer also confirmed that the patient survived the event and was transferred to the hospital.
Event or Problem Description
The customer contacted physio-control to report that their device unexpectedly powered off multiple times during a patient event.There were no reports of any adverse effects to the patient as a result of the reported issue.

• 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: 9889496
• Report Number: 0003015876-2020-00439
• Device Sequence Number: 16723923
• Product Code: MKJ
• UDI-Device Identifier: 00883873872048
• UDI-Public: 00883873872048
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2020

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: 99577-001935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Received by Manufacturer: 03/01/2020
• Supplement Date Received by Manufacturer: 04/13/2020; 05/26/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 05/12/2020; 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 54