MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 12 DEFIBRILLATOR/MONITOR SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number	99400-002505
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and could not duplicate the reported issue.Physio completed unrelated repairs and after observing proper device operation through functional and performance testing the unit was returned to the customer for use.The cause of the reported issue could not be conclusively determined.
Event or Problem Description
The customer contacted physio-control to report that the device is unable to monitor paddles ecg.As a result, defibrillation therapy may not be available to a patient if needed.There was no patient use associated with the reported issue.
Additional Manufacturer Narrative
Physio further evaluated the reported issue and determined the report of the device being unable to monitor paddles ecg was recorded in error.The hospital biomed did not recall any issues with the displayed paddles lead ecg.
Event or Problem Description
The customer contacted physio-control to report that the device is unable to monitor paddles ecg.As a result, defibrillation therapy may not be available to a patient if needed.There was no patient use associated with the reported issue.

• Brand Name: LIFEPAK® 12 DEFIBRILLATOR/MONITOR SERIES
• 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: 8135920
• Report Number: 0003015876-2018-02065
• Device Sequence Number: 16685916
• Product Code: MKJ
• UDI-Device Identifier: 00885074269252
• UDI-Public: 00885074269252
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K102972
• 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): 01/22/2019

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 Catalogue Number: 99400-002505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1