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	12/10/2019
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 customers device and was unable to duplicate the reported issue.After tightening the battery pins and nuts on the backside as a precaution, proper device operation was observed through functional and performance testing and the device was returned to the customer for use.
Event or Problem Description
The customer contacted physio-control to report that their device turned off twice during a call.In this state the device would not be able to deliver defibrillation therapy if needed.There was no report of any adverse effect to the patient as a result of the reported issue.
Event or Problem Description
The customer contacted physio-control to report that their device turned off twice during a call.In this state the device would not be able to deliver defibrillation therapy if needed.There was no report of any adverse effect to the patient as a result of the reported issue.
Additional Manufacturer Narrative
Physio-control evaluated the device download information and verified that the device unexpectedly lost power twelve times on the event date.The cause of the reported issue is unknown.Section h10/h11 additional mfg narrative of the initial medwatch report indicated: 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 customers device and was unable to duplicate the reported issue.After tightening the battery pins and nuts on the backside as a precaution, proper device operation was observed through functional and performance testing and the device was returned to the customer for use.Section h10/h11 additional mfg narrative of the initial medwatch report should indicate: 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 customers device and was unable to duplicate the reported issue.The battery pins and nuts on the backside were inspected and in acceptable condition and tight.Proper device operation was observed through functional and performance testing and the device was returned to the customer for use.

• 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: 9558877
• Report Number: 0003015876-2020-00047
• Device Sequence Number: 2245959
• Product Code: MKJ
• UDI-Device Identifier: 00883873979419
• UDI-Public: 00883873979419
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

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: 99577-000056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1