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	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer was able to provide some patient information.Patient fields in which information were not provided by the customer were intentionally left blank.Physio-control evaluated the customer¿s device and was unable to duplicate the reported issue.Physio replaced the battery pins in the device and battery wire harness as a precaution as it was observed to be worn.Thereafter proper device operation was observed through functional and performance testing and the device was returned to the customer for use.Physio downloaded the electronic records from the customer¿s device and was able to confirm that their device experienced multiple inappropriate loss of power.
Event or Problem Description
The customer contacted physio-control to report that their device powered off by itself twice during a patient event.The customer advised this occurred while monitoring the patient's ecg rhythm.There were no adverse effects to the patient reported as a result of this 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: 11990650
• Report Number: 0003015876-2021-01221
• Device Sequence Number: 845090
• Product Code: MKJ
• UDI-Device Identifier: 00883873912799
• UDI-Public: 00883873912799
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2021

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: 99577-001217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR